MAUDE Adverse Event Report: COVIDIEN LP CAPROSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number SC-5617G

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2022

Event Type  malfunction  

Event Description

4-0 caprosyn p-12 cutting needle suture sc-5617g used to close skin incision malfunctioned due to needle point being blunt instead of sharp.Surgeon and pa noticed the needle was not smoothly going through skin edges.Upon looking and comparing needles, one appeared obviously different.Magnifying lens was used.No apparent breakage to report.

• Brand Name: CAPROSYN
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13365952
• MDR Text Key: 284520539
• Report Number: 13365952
• Device Sequence Number: 1
• Product Code: GAM
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC-5617G
• Device Catalogue Number: SC-5617G
• Device Lot Number: D1F0212FY AND D0H1650FY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Sex: Female