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

Model Number	119110
Medical Device Problem Codes	Restricted Flow rate (1248); Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/28/2018
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 there was no drainage eye on the catheter.Then the catheter was removed and replaced.
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7349097
• Report Number: 1018233-2018-00839
• Device Sequence Number: 19200109
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/16/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 05/10/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1