MAUDE Adverse Event Report: ETHICON, LLC PDS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number Z347H

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

Event Description

When pulling the suture through the skin the needle peeled back.It released the suture.The needle did not break, and all pieces were intact, just the thread was released.Manufacturer response for pds*ii suture, ethicon (per site reporter) none to date.

• Brand Name: PDS
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, LLC; 475 c street los frailes industrial park, suite 401; guaynabo PA 00969
• MDR Report Key: 9621334
• MDR Text Key: 176068719
• Report Number: 9621334
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2020,05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z347H
• Device Catalogue Number: Z347H
• Device Lot Number: MLZ270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1