MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 TEMPORARY PACING ELECTRODE CATHETER

Model Number	106173P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
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.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.
Event or Problem Description
It was reported that customer had a product failure with the temporary pacing electrode catheter in the intensive care unit.The balloon did not inflate when physician attempted.Also stated that they had the failed component in their office for investigation, which was a part of a kit that they did not carry.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The product was used for patient treatment.The product caused the reported failure.The temporary pacing electrode catheter with syringe was returned without the original packaging.Visual evaluation: a tear was noted to be present in the balloon where it connects to the rest of the device.Attempted to inflate the balloon with the returned syringe, however the balloon could not be inflated as the air leaked through the tear.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." 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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that customer had a product failure with the temporary pacing electrode catheter in the intensive care unit.The balloon did not inflate when physician attempted.Also stated that they had the failed component in their office for investigation, which was a part of a kit that they did not carry.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Common Device Name: TEMPORARY PACING ELECTRODE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17078840
• Report Number: 1018233-2023-04080
• Device Sequence Number: 19376501
• Product Code: LDF
• UDI-Device Identifier: 00801741011573
• UDI-Public: (01)00801741011573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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 Model Number: 106173P
• Device Catalogue Number: 106173P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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