MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PATTIE 1X1; PATTIE, COTTONOID

Model Number	24-5407
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.
Event or Problem Description
As reported by the distributor, contaminants were found on codman surgical patties.There were no reports of delay or patient harm.

• Brand Name: BULK SURG PATTIE 1X1
• Common Device Name: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7735176
• Report Number: 1226348-2018-10524
• Device Sequence Number: 16789342
• Product Code: HBA
• UDI-Device Identifier: 20886704004162
• UDI-Public: (01)20886704004162(11)180214(10)HU3656
• 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
• 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: 24-5407
• Device Catalogue Number: 24-5407
• Device Lot Number: HU3656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1