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 Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the distributor, brown crusty material was found on surgical patties prior to a surgery.The entire or needed to be re-done to use new components of a new pack resulting in a surgical delay.

Manufacturer Narrative

Updated udi -- (b)(4).It was previously reported that the device would be returned for evaluation.Multiple attempts to obtain the sample have not been successful.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 issues.At present, we consider this complaint 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7379288
• MDR Text Key: 103747418
• Report Number: 1226348-2018-10247
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-5412
• Device Lot Number: HB2954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other