MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/2 X 6; COTTONOID, PADDIE

Catalog Number 245432

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint sample was not returned for evaluation however, a photo was provided.Complaint of miscount for 11 of 10 patties was confirmed.Applicable device history records (dhrs) were reviewed and no anomalies were found.Per the requirements of the specification, the operator is required to confirm the number of surgical strips prior to sealing them in the package.Based on the information provided, it is likely that the operator miscounted the strips.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Photo evaluation.

Event Description

As reported by the distributor, a 10 pack of surgical strips contained 11.There were no reports of delay or patient harm.The product will not be returned but a photo is available.

• Brand Name: BULK SURG STRIP 1/2 X 6
• Type of Device: COTTONOID, PADDIE
• 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: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8169343
• MDR Text Key: 130505633
• Report Number: 1226348-2018-10884
• 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
• Report Date: 12/10/2018

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
• Device Operator: Other
• Device Catalogue Number: 245432
• Device Lot Number: HZ5005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1