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

Model Number	119108
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
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 bd represents all 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 bd.The device was not returned.
Event or Problem Description
It was reported that the sensica device was not recognizing the temperature foley catheter.It was stated that initially the device showed 35.3c as a low temperature and 43.0c as a high temperature, but later it was only showing.The user was able to obtain a cord to connect the foley catheter with the monoplug adaptor to their monitor instead.It was still not displaying the temperature and there was an alarm notification ¿temperature out of range.¿.
Event or Problem Description
It was reported that the sensica device was not recognizing the temperature foley catheter.It was stated that initially the device showed 35.3c as a low temperature and 43.0c as a high temperature, but later it was only showing ¿****¿.The user was able to obtain a cord to connect the foley catheter with the monoplug adaptor to their monitor instead.It was still not displaying the temperature and there was an alarm notification ¿temperature out of range.¿.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d,g h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "sensor wire too weak / handling damaged".It is unknown whether the device had met relevant specifications.The product was used for treatment purpose.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.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.A labeling review can not be performed because only the catheter sub-assembly number was provided not the finished catheter or tray pcn.The device was not returned.
Event or Problem Description
It was reported that the sensica device was not recognizing the temperature foley catheter.It was stated that initially the device showed 35.3c as a low temperature and 43.0c as a high temperature, but later it was only showing ¿****¿.The user was able to obtain a cord to connect the foley catheter with the monoplug adaptor to their monitor instead.It was still not displaying the temperature and there was an alarm notification ¿temperature out of range.¿.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING PEDIATRIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14142641
• Report Number: 1018233-2022-02699
• Device Sequence Number: 3986585
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2022

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: 06/18/2026
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGFT1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 10/18/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 10/04/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown