MAUDE Adverse Event Report: ETHICON PDS SUTURE ON CTX NEEDLE; NEEDLE, SUTURE

Model Number Z370

Device Problem Component Missing (2306)

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

Event Date 10/05/2015

Event Type  malfunction  

Event Description

When closing fascia it was noted that the tip of the ctx needle was missing.

• Brand Name: PDS SUTURE ON CTX NEEDLE
• Type of Device: NEEDLE, SUTURE
• Manufacturer (Section D): ETHICON; rt. 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 5426846
• MDR Text Key: 37937127
• Report Number: 5426846
• Device Sequence Number: 0
• Product Code: NEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: Z370
• Device Catalogue Number: EHZ349
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 75