MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number ZB346

Device Problem Component Misassembled (4004)

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was found that there was a different product in the package.There were no adverse consequences to the patient.Additional information was requested.

Manufacturer Narrative

Product complaint # (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.(b)(4).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.Additional information was requested, and the following was obtained: was the product used in the patient? no.Please describe the sterile packaging: were there any issues with the seal of the sterile packaging? no.Are there any tears/holes in the sterile packaging? no.Please provide any information relating to how a different product was found in the package? a suture seemed to be vicryl was found in the package.What was the product code and lot number found in the package? product code is zb346 and the possible lot number is rgmmkc or rkmatc.Was the different product found in the primary package or was the different product found in the box? primary package.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch rgmmkc.Batch rkmatc.A manufacturing record evaluation was performed for the finished device rgmmkc batch number, and no non-conformances were identified.Expiration date: may/31/2026 date of mfg.: jun/23/2021.A manufacturing record evaluation was performed for the finished device rkmatc batch number, and no non-conformances were identified.Expiration date: aug/31/2026 date of mfg.: sep/2/2021.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/21/2022.H6 component code: g07002 no device problem found.Additional information was requested, the following was obtained: it was reported that the sales rep received the product in apr.The alert date is (b)(6) 2022.Please clarify which date is correct.: the alert date is (b)(6) 2022.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample revealed that one empty opened foil that pertain to product code zb346, lot rgmmkc, one empty opened foil that pertain to product code zb346, lot rkmatc, two labeled winding formers with an undispensed strand and one paper lid that pertain to product code zb346 and one empty winding former were returned for analysis.In addition, a strand that pertains to an unknown product code vicryl violet was returned for evaluation.Upon visual inspection of the foils received; one of the foils belongs to product code zb346, lot number rgmmkc manufactured on jun/23/2021.The second foil belongs to product code zb346, lot number rkmatc manufactured on sep/2/2021.According to manufacturing dates, there are differences of three months between each of the other.These batches could not be mixed during the manufacturing process.In addition, the pds product was observed with a drilled permanent attachment and the vicryl is a control release needle suture.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.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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 36IN 0 S/A CTB-1
• 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; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15879807
• MDR Text Key: 307785699
• Report Number: 2210968-2022-09833
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031062047
• UDI-Public: 10705031062047
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZB346
• Device Catalogue Number: ZB346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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