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

Catalog Number 24-5412

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation or other relevant information, a follow-up report will be submitted.

Event Description

As reported by the distributor, a bug was found inside the package of surgical patties.Photos have been provided.There were no reports of delay or patient harm.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Product sample was received with an insect confirmed to be present in the bulk bag.A review of manufacturing records found no discrepancies when the device was released to stock.The product met the product specifications when leaving the facility.Quality assurance inspects the product per procedure and no foreign material was found at this time.Based on the returned sample, the reported issue was confirmed; however, with the available information, it cannot be confirmed when or where the foreign material entered the bag.Trends will be monitored for this and similar issues.At present, we consider this compliant to be closed.

• Brand Name: BULK SURG PAT 1X3
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8034320
• MDR Text Key: 127874519
• Report Number: 1226348-2018-10798
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 24-5412
• Device Lot Number: J0044M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1