MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 3-0 S/A X-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z458E

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device pck957 batch number, and no non-conformances were identified.Investigation summary: it was received for analysis an open sample of product code z458e, lot pck957.During the visual inspection of sample, the swage and attachment area of the needle were noted to be as expected, suture remnant was noted at the barrel hole.The suture could not be dispensed since have begun with the process of degradation and this caused that the needle was detached of the suture.The functional test cannot be performed.The foil present excessive handling and multiples wrinkles and holes were noted.This condition contributed to degradation of the suture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to visual inspection the assignable cause of the detached needle, was caused by suture degradation exposure to environment.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.When opening the package, it was found that the suture had been detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.Upon evaluation of the returned device, the foil presented with excessive handling and multiples wrinkles and holes were noted.This condition contributed to degradation of the suture.No additional information was provided.

• Brand Name: PDSII CLR 27IN 3-0 S/A X-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10325545
• MDR Text Key: 200394020
• Report Number: 2210968-2020-05567
• Device Sequence Number: 1
• Product Code: NEW
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: Z458E
• Device Lot Number: PCK957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1