MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; BARDEX IC FOLEY CATHETER

Model Number	303316A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that urine would not drain from the catheter.
Additional Manufacturer Narrative
Received 1 used latex foley catheter with the original unit packaging.Inflated balloon with 30cc water and administered flow rate testing.While inflated, the flow rate was 150ml/min, 150ml/min and 150ml/min.The internal flow specification for a sample of this product type is 100ml/min minimum, so the sample met the internal flow rate specification.Water was introduced through the drainage eye and came out from drainage funnel without difficulty.Unable to duplicate the reported event.The catheter was dissected and no conditions found that could have contributed to the reported event.From the evaluation, it was unconfirmed that the urine would not drain from the catheter.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "do not reuse.Do not resterilize.Sterile unless package is open or damaged, except for the hand sanitizer and castile soap which are not terminally sterilized." (b)(4).
Event or Problem Description
It was reported that urine would not drain from the catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that urine would not drain from the catheter.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: BARDEX IC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6970043
• Report Number: 1018233-2017-05407
• Device Sequence Number: 1469474
• Product Code: MJC
• UDI-Device Identifier: 00801741024269
• UDI-Public: (01)00801741024269
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 303316A
• Device Catalogue Number: 0165SI16
• Device Lot Number: 7BC5108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 12/14/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 10/27/2017; 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1