BARD CENTER ENTRY FOLEY TRAY - 16FR. LUBRICATH HYDROPHILIC #899716

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for BARD CENTER ENTRY FOLEY TRAY - 16FR. LUBRICATH HYDROPHILIC #899716 manufactured by C.r. Bard, Inc..

Event Text Entries

[2652] 6/4/93 at 2131 71 year old patient with chronic respiratory disease to er with respiratory failure. Responded well to initial bronchodilator treatment & aminophylline infusion. At 2230 a foley catheter was inserted without difficulty. It had been in place approximately 10 minutes and had drained 75cc urine when "there was a pop sensation heard and the patient noted lower abdominal pain in the rectal prostate region". The catheter self-extruded with a ruptured foley balloon. There was some minimal bleeding noted. A 24 fr foley was placed with no return, removed. A 16 fr foley was attempted & discontinued when it met resistence. A supra public drainage tube was then inserted with 800cc of urine obtained after patient was given iv lasix. (diagnosis: respiratory failure, asthma, copd, mi, and urethral trauma. ) patient initially had difficulty voiding and then had trouble with post voiding residuals. There was also swelling of the penis and scrotal skin. A consult with a urologist was obtained on 6/7. As of 6/10, patient began to boid in significant amounts with the supra catheter clamped. It was discontinued 6/11 and the patient was discharged home. Device 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 not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, telemetry failure, unanticipated short term complication of procedure, balloon. Conclusion: device failure directly caused event, device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5781
• MDR Report Key: 5781
• Date Received: 1993-07-01
• Date of Report: 1993-06-10
• Date of Event: 1993-06-04
• Date Facility Aware: 1993-06-04
• Report Date: 1993-06-10
• Date Reported to FDA: 1993-06-10
• Date Reported to Mfgr: 1993-06-10
• Date Added to Maude: 1993-07-27
• 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: BARD CENTER ENTRY FOLEY TRAY - 16FR. LUBRICATH HYDROPHILIC
• Generic Name: COATED TO PRECONNECTED DRAINAGE SYSTEM
• Product Code: EYZ
• Date Received: 1993-07-01
• Model Number: NA
• Catalog Number: #899716
• Lot Number: 76JC2031
• ID Number: NA
• Device Expiration Date: 1995-05-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-MAY-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5480
• Manufacturer: C.R. BARD, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-01