MAUDE Adverse Event Report: CP MEDICAL PGA; POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE

Model Number	423AC-HSM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary report.Pending patient information.
Event or Problem Description
It was reported that pga suture breaking for closure of arms and legs, needle bending and difficulty with dispensing from racetrack requiring "extended pressure".(lot# 180413-53) these failures occurred with several patients requiring extra sutures or a new suture for closure.The number of patients involved is approximately 10 but the exact number is unknown.These patients did not experience any adverse effects.It is unknown if there was a delay in surgery greater than 30 minutes.

• Brand Name: PGA
• Common Device Name: POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8593266
• Report Number: 3012164473-2019-00014
• Device Sequence Number: 2293882
• Product Code: GAM
• UDI-Device Identifier: 00304040081358
• UDI-Public: 00304040081358
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K002190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 423AC-HSM
• Device Catalogue Number: 423AC-HSM
• Device Lot Number: 180413-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1