MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number Z305H

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that an animal underwent an unknown procedure in 2022 and suture was used.Before use on the patient, it was reported by the account contact that they purchased 2-0 pds*ii w/ sh taper needle from mwi animal health.Inside the box is 2-0 pds*ii w/cp-1 needle.No patient involvement was reported.Device will be returned.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/10/2023.A device has been received for product z466, lot qbmqc, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A device has been received for product z317, lot sbmphr, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A device has been received for product z305h, lot semlrx, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Our failure analysis lab received the additional products with reference to this complaint, the following product was received: product code: z466 lot: qbmqc.Product code: z317 lot: sbmphr.Could you please clarify if the additional devices belongs to this complaint? if yes, please provide the product code and lot number for the unknown product did a device malfunction occur during the same procedure for all three products; product code z466/lot qbmqc, product code z317/lot sbmphr, & z305h/lot semlrx? if not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.If the device was not reported before, please provide more details of device malfunction.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/10/2023.H6 component code: g07002 device not returned.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: photo show an open box with product code z317h, lot no.Semrlx, expiration date 2027-04-30 and a foil pack with product code z466, lot no.Qbmqcp, expiration date 2025-01-31.Based on the manufacturing dates, there is a difference of two years between the two batches of products.Due to the difference in dates, it is not possible that it was mixed during the manufacturing process.During the packaging process, each barcode on the box and label is scanned into the system to compare the information.According to result obtained during the investigation, the reported complaint could not be confirmed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/10/2023.Devices have been received for product code z466, lot qbmqc and z317h, lot semlrx, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device semrlx/ z317h38 batch number, and no non-conformances were identified.Expiration date: apr/30/2027.Date of mfg.: may/30/2022.A manufacturing record evaluation was performed for the finished device qbmqcp/ z466h50 batch number, and no non-conformances were identified.Expiration date: jan/30/2025.Date of mfg.: feb/21/2020.The following information was requested: our failure analysis lab received an additional product with reference to this complaint: product code: z317.Lot: sbmphr.Why was z317h lot sbmphr returned? was this returned in error? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/17/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned devices.Visual analysis of the returned sample determined that it was received one box with thirty-five unopened samples.Upon initial inspection of the box received, it was found thirty-three unopened samples of product code z466, lot qbmqcp and two unopened samples of product code z317, lot # semrlx.As per the visual inspection of the samples received, the product belongs to different product codes and lot numbers, for this reason the needles are different.Due to the mismatch observed, a further investigation was performed and in conclusion the following was observed: thirty-three samples belong to code product code z466, lot qbmqcp, manufactured on 02/21/2020 and the expiry date on 01/ 31/2025.Eleven samples belong to product code z317, lot # semrlx, manufactured on 05/30/2022 and the expiry date on 04/ 30/2027.The products were manufactured with a difference of two years, and it is not possible that it has been mixed during manufacturing process.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no product defect was identified, there may have been other circumstances or issues that occurred during the handling of the product out of the ethicon process.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, the following was obtained: in response to your question about why i sent in the pds #2-0 sh z317h, mwi requested i contact you regarding the replacement of the suture that was incorrectly packaged.I filled out the form online and was sent a fedex package with instructions to return the pds #2-0 sh z317h box within the same box.The following additional information was requested: we are trying to determine if the product code z317h, lot sbmphr was returned in error or was this lot also included in this complaint? we received the following three returned products.Product code z317h, lot semlrx.Product code z466, lot qbmqcp.Product code z317h, lot sbmphr.Product code z317h, lot semlrx and z466, lot qbmqcp belongs to this complaint.Please clarify the reason z317h, lot sbmphr was returned.If the product z317h, lot sbmphr was involved in this complaint, please explain the issue with the additional returned product.Additional information was requested, the following was obtained: to my knowledge only product code z317h, lot semlrx with product code z466, lot qbmqcp inside was sent to ethicon from the carlson college of veterinary medicine, student teaching laboratory.I do not have knowledge of why z317h, lot sbmphr was returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII VIO 27IN 2-0 S/A SH
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16014651
• MDR Text Key: 308234717
• Report Number: 2210968-2022-10456
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031060494
• UDI-Public: 10705031060494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z305H
• Device Catalogue Number: Z317H
• Device Lot Number: SEMLRX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1