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

Catalog Number 0165SI18

Device Problems Inflation Problem (1310); Mushroomed (2987)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

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.Sample was discarded.

Event Description

It was reported that the balloon of the foley would not blow up.

Manufacturer Narrative

The device was not returned for evaluation.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: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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.The device was not returned.

Event Description

It was reported that the balloon of the foley would not inflate.

Manufacturer Narrative

The reported event was confirmed with an unknown cause.Received only a photo of the catheter from medicon for evaluation.Based on the photo, it was observed that the balloon was slightly baggy at the sac collar.The exact cause of the failure could not be determined since a functional test was unable to be performed without a physical sample.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: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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 Description

It was reported that the balloon of the foley would not inflate.Per additional information received, it was noted that the balloon inflated predominantly on one side.

Manufacturer Narrative

Received catheter in open package and leaflet for evaluation.The reported event was unconfirmed.The exterior of the sample was visually inspected and did not find any evidence of a failure that would support the reported event.No pinch or blockage was observed and the balloon was not mushroomed.There was evidence that the catheter had been used by the patient.Based on the sample appearance, it looked old and it seemed that it had been used a long time ago.Per the functional evaluation, the balloon was deflated and observed yellow liquid from the balloon about 0.1 ml.The returned catheter met specification and was able to deflate and inflate without difficulty.The following results were found during the dimensional evaluation: concentricity (full inflation volume) - 60/40.Eye snip length - 3/32.Eye snip width - 2/32.Eye snip distance from distal cuff - 10/32.Eye snip distance from proximal cuff - 9/32.Average sac thickness - 26 thou.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: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 Description

It was reported that the balloon of the foley would not inflate.Per additional information received, it was noted that the balloon inflated predominantly on one side.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5699712
• MDR Text Key: 47730690
• Report Number: 1018233-2016-00713
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 0165SI18
• Device Lot Number: 5CK7066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided; 02/28/2018; 04/25/2018
• Supplement Dates FDA Received: 06/11/2016; 02/28/2018; 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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