MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1X3; PATTIE, COTTONOID

Model Number 80-1408

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

As reported by the affiliate, the sterile packaging of surgical patties had been breached.Another pack was used to complete the procedure.There were no reports of delays or patient harm.

Manufacturer Narrative

Corrected fields: device available for evaluation.It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.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 or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: SURG PAT XRAY 1X3
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7744066
• MDR Text Key: 115906754
• Report Number: 1226348-2018-10557
• Device Sequence Number: 1
• Product Code: HBA
• UDI-Device Identifier: 20886704036552
• UDI-Public: (01)20886704036552(10)H82036
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80-1408
• Device Catalogue Number: 80-1408
• Device Lot Number: H82036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1