MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1 1/2; PATTIE, COTTONOID

Model Number	24-5408
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the distributor, a pack of codman patties had one sponge missing a string.Pattie pack was pulled from stock.There were no reports of delay or patient harm.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
A single pattie was returned for evaluation.With only one pattie returned, the reported issue of a missing device could not be confirmed.The product that was returned has a partial string attached.We are unable to determine at what point the string was damaged.No lot number was provided; therefore, a review a manufacturing records could not be performed.Based on the information provided, no root cause conclusion can be drawn.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: BULK SURG PAT 1/2 X 1 1/2
• Common Device Name: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7735303
• Report Number: 1226348-2018-10525
• Device Sequence Number: 752154
• Product Code: HBA
• UDI-Device Identifier: 20886704004179
• UDI-Public: (01)20886704004179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2018

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: 24-5408
• Device Catalogue Number: 24-5408
• Device Lot Number: 500308817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 09/07/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1