MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 8762H

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

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 the patient underwent an unknown cardiovascular surgery on (b)(6)2017 and the suture was used.During the procedure, it was found that the shape of the needle was different than it should be.There were no adverse patient consequences reported.No further information is available.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The needle/suture was received for evaluation.Visual inspection revealed that the needle did not correspond to the product code.According to the sample condition it was observed an incorrect component.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Received suture segments with needles.According to the sample condition it was observed an incorrect component.One of the segments has an sh-1 needle, which matches the batch needle requirements.The other segment has a bb-1 needle which does not match the product code (no sh needle match was found).Incident batch was manufactured on 08/21/2013 through the mas # 6.Mas# 6 manufacturing sequence was verified until 4th previous batch and none of them was found with a bb-1 needle.Although the other needle does not match the sh template, and it was also verified until the 4th previous batch manufactured in mas# 6 and did not match any of the 4 previous batches.For this reason, the cause of this mix could not be internal.

Manufacturer Narrative

The needle/suture was received for evaluation.Visual inspection revealed that the needle did not correspond to the product code.According to the sample condition it was observed an incorrect component.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6402393
• MDR Text Key: 69875133
• Report Number: 2210968-2017-31158
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133356
• 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,Followup,Followup,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 8762H
• Device Lot Number: GJP474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• 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