MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE; PATTIE, COTTONOID

Catalog Number 80-1402

Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 10/23/2017

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 ous rep, a 10 pack of surgical patties contained 12: 10 with strings and 2 without.There were no reports of delay or patient harm.

Manufacturer Narrative

(b)(4).Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the samples were received and reviewed.Pattie miscount was confirmed.12 patties present, 2 missing strings.Dhr review conducted and tcr opened for pattie miscount.We will continue to monitor for this or similar complaints for this product code.Samples confirmed and dhr reviewed.No issues present on dhr.Pull tests were all within acceptable range.These patties are produced in a hybrid machine where 10 patties are put in a stack and passed to the operator.The operator manually inspects the patties and wraps the string on the card.During the production, it appears the string was pulled off the 2 patties prior to being stacked.The operator likely noticed 2 strings missing from the card, assumed a miscount, and added 2 patties with strings resulting in 12 patties on the card.Tcr was opened for a miscount as a result of this error.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.

• Brand Name: CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE
• Type of Device: PATTIE, 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: 7026408
• MDR Text Key: 92908650
• Report Number: 1226348-2017-10828
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1402
• Device Lot Number: H82350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• 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
• Patient Sequence Number: 1