MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 3/4 X 3/4; PADDIE, COTTONOID

Model Number	24-5405
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the distributor, a 10-pack of surgical patties contained nine.The event was not discovered intra-operatively.There were no reports of delay or patient harm.
Additional Manufacturer Narrative
The device was returned for evaluation.It was confirmed that there were nine patties rather than 10.A review of the dhr found no discrepancies.Root cause is likely due to operator error.The operator is required to inspect the front and back of the patties and also count the amount of surgical patties.Operators are trained to wrap each string onto a counting card to make it very visible and to confirm that there are only 10 surgical patties on the card.Retraining was initiated to address this issue.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: BULK SURG PAT 3/4 X 3/4
• Common Device Name: PADDIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7742670
• Report Number: 1226348-2018-10551
• Device Sequence Number: 1405097
• Product Code: HBA
• UDI-Device Identifier: 20886704004148
• UDI-Public: (01)20886704004148(10)HR3019
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: Other
• Device Model Number: 24-5405
• Device Catalogue Number: 24-5405
• Device Lot Number: HR3019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1