DAVOL 60004-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for DAVOL 60004-2 manufactured by Bard.

Event Text Entries

[19551574] 2 1/2 months old male with prior history of 3 operations for necrotizing entrocolitis & evisceration. Exploratory surgery performed in hope of excising the bowel & covering with mercilenu mesh or caver skin. During surgery, fairly large amount of blood loss were noted & transfusion continued. During the disection of the mesentery, it was observed that hardly any blood flow at the disection. Surgeon the disection. Surgeon proceed to close. Patient went into cardiac arrest. Resusitation continued for 20-25 minutes. Patient was pronounced dead. As patient was undrape catheter was found to have a hole at approximately at the hub. There were clear sign of leak age & towels under the patient were soaked with blood. Catheter was inserted prior to surgery by staff physician 24 days ago in nicu. The catheter was impounded for investigation. Ecri was consulted via telephone by risk management. Upon closer visual inspection of the catheter by hospital biomedical engineering manager and risk managment director on 3/3/92, it was observed that the hole in question did not seem like a rupture of the catheter. It was further observed that the breakage in the catheter seems more of a wedge shape which looked more like "," in shape. It is unclear at this time as to the cause of breakage in the catheter that contributed to this eventdevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed, visual examination. Results of evaluation: telemetry failure, other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4255
• MDR Report Key: 4255
• Date Received: 1992-07-23
• Date of Report: 1992-03-04
• Date of Event: 1992-02-20
• Date Facility Aware: 1992-02-20
• Report Date: 1992-03-04
• Date Reported to Mfgr: 1992-03-04
• Date Added to Maude: 1993-05-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DAVOL
• Generic Name: 2.7 F PEDS SINGLE LUMEN VASCULAR CATHETER
• Product Code: GBN
• Date Received: 1992-07-23
• Model Number: 60004-2
• Catalog Number: 60004-2
• Lot Number: 36DB4658
• ID Number: H30360004214
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3981
• Manufacturer: BARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-07-23