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

Catalog Number 24-5432

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, it was noted that the operators are required to 100 % inspect all the strips before they are packaged. The strip machine ran out of x-ray monofilament and operator missed the full inspection. A ilc was opened to make the operator aware of the complaint. A retraining was conducted to assist the operator in the future. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.

Manufacturer Narrative

(b)(4). Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the distributor, one surgical strip had the radiopaque line only half way down the cottonoid. Distributor will return for evaluation.

• 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 Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6661611
• MDR Text Key: 130225800
• Report Number: 1226348-2017-10426
• 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: health professional

Reporter Occupation

• Type of Report: Initial,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 24-5432
• Device Lot Number: H33014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial