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

Model Number	119116
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 the catheter leaked from an unknown source.No patient injury was reported.
Additional Manufacturer Narrative
The reported issue (it was reported that the catheter leaked from an unknown source.No patient injury reported.Per medwatch: the plastic portion of the drainage bag where it connects to the urometer is leaking) was unconfirmed, the problem could not be reproduced.While evaluating the sample received per visual evaluation no obvious defects were observed.Per functional evaluation the balloon was inflated with 10cc of tap water mixed with blue methylene and no leakage was found.The catheter balloon was deflated by itself and the 10cc of water was recovered.Then, water was injected for the drainage lumen and no leakage was found.Per dimensional evaluation the balloon symmetry was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water.12 fr.(5cc balloon): use 5.5cc sterile water.14 fr.And larger (5cc balloon): use 10cc sterile water.Do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the catheter leaked from an unknown source.No patient injury was reported.Per medwatch: the plastic portion of the drainage bag, where it connects to the urometer was leaking.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: TEMP. SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6723918
• Report Number: 1018233-2017-03806
• Device Sequence Number: 881686
• Product Code: EZL
• UDI-Device Identifier: 00801741046032
• UDI-Public: (01)00801741046032
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 03/31/2022
• Device Model Number: 119116
• Device Catalogue Number: 119116
• Device Lot Number: NGBQ2678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR