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

Model Number	119116
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
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.
Event or Problem Description
It was reported that the foley catheter had been in the patient for only few hours and it was noticed that the temperature cable inside of the foley was unraveling and distorting the catheter.There was no travelling or unusual manipulation of the foley was reported.It was removed and replaced, also patient was not harmed.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone temperature sensing foley with manufacturing lot number ngeu4022.Visual inspection of the sample noted that when the catheter was not held straight, the tension from the thermistor wires caused protrusions in the shaft and bends at many locations.This caused the catheter shaft to greatly distort and twist.This does not meet the specification as "the wire should not be kinked, knotted or broken once is inserted in the lumen." a potential root cause for this failure could be "after insertion, catheter is stretched (in cleaning)." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter." corrections: d, h.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the foley catheter had been in the patient for only few hours, and it was noticed that the temperature cable inside of the foley was unraveling and distorting the catheter.There was no travelling or unusual manipulation of the foley was reported.It was removed and replaced, also patient was not harmed.

• Brand Name: BARDEX ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11490405
• Report Number: 1018233-2021-01301
• Device Sequence Number: 2857225
• Product Code: EZL
• UDI-Device Identifier: 00801741046032
• UDI-Public: (01)00801741046032
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: Lay User/Patient
• Device Expiration Date: 08/07/2025
• Device Model Number: 119116
• Device Catalogue Number: 119116
• Device Lot Number: NGEU4022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other