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); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).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.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 or similar complaints.At present, we consider this complaint to be closed.

Event Description

It was reported that when the surgical pattie product packaging was opened prior to a case starting, there were 11 patties instead of 10.The extra pattie also did not have a thread attached to it.There was no delay in the procedure,the patient was not affected and the situation was remedied by opening another pack from a different batch.

• 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 (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: 8309802
• MDR Text Key: 137559449
• Report Number: 1226348-2019-10076
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2019

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: 80-1402
• Device Lot Number: HZ1253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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