MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 8-18" (45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z771D

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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) 2018, and suture was used.During the procedure, it was found that a device of a different product code had been in the package when opening the package.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: four empty opened foils of subject product with two paper lids and two winding former of another product were returned for analysis.In addition, two opened boxes with thirteen and nine unopened samples of subject product were returned for analysis.Additional foils of subject product from two other lots were received.During the visual inspection of the opened samples, mismatch between foils and paper lids could be observed.The foils belonged to the subject product, but the paper lids and the product inside belonged to the other product.Twenty two unopened samples were reviewed, eight present mismatches between foils and paper lids.The rest of the samples were as expected.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the two opened samples and eight representative samples received, the assignable cause of the incorrect component assembly is a mixed product code.Per the condition of fourteen representative samples received, no incorrect component assembly was observed.

• Brand Name: PDS II SUTURE 8-18" (45CM) 4-0 VIO
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8266497
• MDR Text Key: 133742113
• Report Number: 2210968-2019-78535
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: Z771D
• Device Lot Number: MKK001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 01/27/2019
• Patient Sequence Number: 1