MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 3/4 X 6; PADDIE, COTTONOID

Catalog Number 24-5433

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the distributor, a 10- pack of surgical strips were received with 9 strips.Sample is available to return.

Manufacturer Narrative

Updated udi: (b)(4).Additional info: describe event or problem, model #/lot #, date received by mfr, type of reports, if follow-up, what type?, additional mfr narrative.Received lot number.Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by distributor, lot number is 610542.

Manufacturer Narrative

The product was returned for evaluation.The issue reported by the customer was confirmed.The manufacturing documentation was pulled and reviewed.No discrepancies were noted.While we are unable to conclusively determine the specific root caused based on the information available, the issue is likely due to operator error.Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack.The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack.Operators who worked on this product and lot number were made aware of the issue and retrained.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: BULK SURG STRIP 3/4 X 6
• Type of Device: PADDIE, COTTONOID
• 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: 6306931
• MDR Text Key: 66679511
• Report Number: 1226348-2017-10090
• 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,Followup

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: Health Professional
• Device Catalogue Number: 24-5433
• Device Lot Number: 610542
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 06/02/2017
• 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
• Patient Sequence Number: 1