MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8581H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2022 and suture was used.The needle snapped off without pressure or pulling.There were no adverse patient consequences reported.Additional information has been requested.
Additional 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 are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? were x-rays taken to locate the needle? was there any patient consequence or injury? what is the patient¿s current health status and condition? was any other tissue damaged as a result of searching the needle? attempts are being 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.(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/19/2022.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.Additional information was requested, and the following was obtained: did the needle fall into the patient? no.If yes, was the needle piece removed from the patient during the same procedure? were x-rays taken to locate the needle? no.Was there any patient consequence or injury? no.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 1/27/2023 h6 component code: g07002 no device problem found additional information: d9, h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample revealed that two opened boxes with twelve and thirty-nine packets each that pertains to product code 8581h were returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.As per the sampling plan, a visual inspection was performed on thirteen samples, the packaging foils were opened, and no defects were detected on the product; the swage and attachment area was noted to be as expected.The needles were intact and no damage, or breakage on the body, tip, or swage area was observed during the evaluation.A functional test was performed, to needle by resistance and met the requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is 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: PRLNE BLU 36IN 4-0 D/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15847219
• Report Number: 2210968-2022-09706
• Device Sequence Number: 17749564
• Product Code: GAW
• UDI-Device Identifier: 10705031017368
• UDI-Public: 10705031017368
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8581H
• Device Catalogue Number: 8581H
• Device Lot Number: SGBCDU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 01/12/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown