MAUDE Adverse Event Report: C.R. BARD, INC. BARD FEMALE CATH KIT; COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER

Catalog Number 0035720

Device Problems Bent (1059); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2017

Event Type  malfunction  

Event Description

Rn inserted catheter to perform a straight cath, was inserted without difficulty, but no urine was obtained.When pulling back to remove the catheter, it was unable to be removed/was stuck.Per palpation, the catheter was felt to be bent.Md was then called and he removed the catheter; and it was found to be bent approx.1 inch from the tip.Per the md's notes: when nurse did urine catheter, the catheter coiled in the urethra and difficult to pull out.The nurse called me and i gently pulled it out and it came out as a whole, no break of the catheter seen.

• Brand Name: BARD FEMALE CATH KIT
• Type of Device: COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6471508
• MDR Text Key: 72094594
• Report Number: 6471508
• Device Sequence Number: 1
• Product Code: FFH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 0035720
• Device Lot Number: NGAX1795
• Other Device ID Number: 8 FR
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 14