MAUDE Adverse Event Report: COVIDIEN POLYSORB; SUTURE NEEDLE

Model Number CL 854

Device Problem Tip breakage (1638)

Patient Problem Cesarean section (c-section) (1774)

Event Date 03/14/2015

Event Type  Injury  

Event Description

While doctor was closing the uterus on a c-section, the tip of a covidien o polysorb cl 854 needle broke off.They were unable to retrieve the piece.Per op report: "unon getting to the end of the last stitch for imbrication, it was noted that the very tip of the needle, approximately 3-4 mm in length was absent." patient was stable and incision closed.Patient was made aware by the surgeon.

• Brand Name: POLYSORB
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfiled MA 02048
• MDR Report Key: 4759653
• MDR Text Key: 5791761
• Report Number: 4759653
• Device Sequence Number: 1
• Product Code: GAM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: CL 854
• Device Lot Number: A4L0942X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2015
• Distributor Facility Aware Date: 03/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 151