MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER; FOLEY CATHETER (SILICONE)

Model Number 119110

Device Problems Restricted Flow rate (1248); Inaccurate Flow Rate (1249); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 02/28/2018

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.

Event Description

It was reported that there was no drainage eye on the catheter.Then the catheter was removed and replaced.

Manufacturer Narrative

Received 11 unopened and 1 used foley catheters for evaluation.The reported event was confirmed as manufacturing related.Per visual evaluation, no defects on the catheter were found.The drainage eyes were correctly perforated.Per the functional evaluation, no water flow was noted through the catheter and obstruction of silicone in the drainage lumen was found in the used sample.The rest of the returned samples were found acceptable.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use state the following: "caution: do not aspirate urine through drainage funnel wall.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.".

Event Description

It was reported that there was no drainage eye on the catheter.Then the catheter was removed and replaced.Per additional information received from the investigation team the eyelets were occluded by the adhesive used in the thermistor.There was no issue with the eyelet punching.

Manufacturer Narrative

Received 11 unopened and 1 used foley catheters for evaluation.The reported event was confirmed as manufacturing related.Per visual evaluation, no defects on the catheter were found.The drainage eyes were correctly perforated.Per the functional evaluation, no water flow was noted through the catheter and obstruction of silicone in the drainage lumen was found in the used sample.The rest of the returned samples were found acceptable.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use state the following: "- caution: do not aspirate urine through drainage funnel wall.- 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." correction: d4.

Event Description

It was reported that there was no drainage eye on the catheter.Then the catheter was removed and replaced.Per additional information received from the investigation team the eyelets were occluded by the adhesive used in the thermistor.There was no issue with the eyelet punching.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7349097
• MDR Text Key: 102891924
• Report Number: 1018233-2018-00839
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 119110
• Device Catalogue Number: 119110
• Device Lot Number: NGAS0312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 05/16/2018
• Supplement Dates FDA Received: 05/10/2018; 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1