MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) BARD WOVEN PHILIPS FOLLOWER URETHRAL CATHETER

Catalog Number 021524

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported that the patient had an anaphylaxis reaction to the product.The symptoms of the anaphylaxis reaction included: hypotension and shortness of breath.The facility reported that filiforms and followers have been resterilized via autoclave.This is the second reaction for this patient.Per additional information the patient was having a cystoscopy and had an anaphylaxis reaction during the procedure.The patient was transferred to the emergency department and treated with benadryl and steroids.Patient was not admitted to the hospital.

Manufacturer Narrative

Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: BARD WOVEN PHILIPS FOLLOWER URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); queensbury NY
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804 204
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4287552
• MDR Text Key: 5086037
• Report Number: 1018233-2014-00328
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 021524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention