MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36IN (90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number EH7585H

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.It was found that a part of the suture had been thin after the package was opened.The product was not used for the patient.There were no adverse patient consequences reported.No additional information is available.

Manufacturer Narrative

Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.Device evaluation summary: the actual device was received for analysis an empty labeled winding former and two needle-suture pieces and of product code eh7585, lot mmj553.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.A needle still has attached a suture piece and the second needle has attached a filament suture to barrel hole.Also, the ends of the sutures were noted cut, present damaged and an elongation due to the stress applied to the strand, this condition causes changes on the suture diameter.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance suture diameter issue was an improper handling.

• Brand Name: PROLENE SUTURE 36IN (90CM) 4-0 BLU
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8855609
• MDR Text Key: 153123795
• Report Number: 2210968-2019-85049
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10705031097254
• UDI-Public: 10705031097254
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: EH7585H
• Device Lot Number: MMJ553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 08/14/2019
• Patient Sequence Number: 1