MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DEBAKEY RING HNDL BD 45D 4-3/4

Catalog Number 320185

Device Problem Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that during vascular surgery for dialysis access, the clamp of the debakey ring handle bulldog (320185) would not close properly to stop blood flow, and the artery kept bleeding out.Additional information has been requested to obtain patient outcome.However, it was reported that no patient death occurred.

Manufacturer Narrative

The debakey ring handle bulldog clamp (320185) was returned for evaluation: visual and functional evaluation of the debakey ring handle bulldog clamp was performed.The returned device was received in used condition with one of the jaws bent away from the other due to rough handling/environmental damage.The reported complaint was confirmed.A bent jaw would prevent proper clamping.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: DEBAKEY RING HNDL BD 45D 4-3/4
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12780052
• MDR Text Key: 280572145
• Report Number: 3014334038-2021-00225
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K102048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320185
• Device Lot Number: AA2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1