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

Model Number 006173P

Device Problem Material Fragmentation (1261)

Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported that the temporary pacing electrode catheter was broken.Also stated that the patient was exposed to hazardous, blood, or bodily fluids.Per additional information via email from ibc on (b)(6) 2023.User exposed to hazardous, blood, or bodily fluids.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the temporary pacing electrode catheter was broken.Also stated that the patient was exposed to hazardous, blood, or bodily fluids.Per additional information via email from ibc on 09feb2023.User exposed to hazardous, blood, or bodily fluids.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event is unconfirmed as the reported event could not be reproduced.No root cause was provided as the reported event was unconfirmed.The used temporary pacing electrode catheter and attached luer syringe were returned without the original packaging.Residue was present on the catheter and syringe from being used on the patient, however, no breaks or visible defects were noted.The balloon was successfully inflated with 1.5cc air using the returned syringe, the stopcock was then closed.After 30 seconds the stopcock was opened and the balloon passively deflated with the syringe attached, meeting specifications.As the reported event is unconfirmed, a dhr review and a label/packaging review is not required.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 actual/suspected device was evaluated.

Event Description

It was reported that the temporary pacing electrode catheter was broken.Also stated that the patient was exposed to hazardous, blood, or bodily fluids.Per additional information via email from ibc on 09feb2023.User exposed to hazardous, blood, or bodily fluids.

• Brand Name: TEMPERATURE PACING ELECTRODE
• Type of Device: TEMPERATURE PACING ELECTRODE
• 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: 16430681
• MDR Text Key: 310238584
• Report Number: 1018233-2023-01162
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFEP1956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other