MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 90CM M1.5; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PEE2993H

Device Problems Break (1069); Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot jm5cqsn, and no non-conformances were identified.Investigation summary: an opened sample of product code of product code pee2993, lot # jm5cqsn, were received for evaluation.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The strand was broken in multiples due to the suture has begun with the process of degradation.The product code pee2993 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The foil was inspected and multiples holes in cavity were noted.This condition contributed to degradation of the 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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.An unopened sample of product code pee2993, lot # jm5cqsn, was received for evaluation.During the visual inspection of the sealed sample, the foil packet was noted with excessive wrinkles, the packet was opened and the swage and the swage and attachment area of the needle were noted to be as expected.The strand was broken in multiples due to the suture has begun with the process of degradation.The product code pee2993 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The foil was inspected and multiples holes in cavity were noted.This condition contributed to degradation of the 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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Note: events reported in 2210968-2021-01666, and 2210968-2021-01667.

Event Description

It was reported that a patient underwent a gastrointestinal procedure on an unknown date and suture was used.During the bile duct ¿ jejunal anastomosis, when holding the needle with a needle-holder, the needle was detached from the suture.There were no adverse consequences to the patient and the patient had been discharged from the hospital.Upon evaluation of the returned device, the strand was broken in multiples due to the suture has begun with the process of degradation.No additional information was provided.

• Brand Name: PDSII VIO 90CM M1.5
• 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.-UK; simpson parkway; kirkton campus; livingston ; UK
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 11361110
• MDR Text Key: 264966088
• Report Number: 2210968-2021-01668
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: PEE2993H
• Device Lot Number: JM5CQSN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1