MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® EXTENSION CABLE

Catalog Number	153622
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
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 the extension cord of the temperature sensing catheter was broken.Stated that the bladder temperature was unable to be measured due to the disconnection of lead wire.
Event or Problem Description
It was reported that the extension cord of the temperature sensing catheter was broken.It was stated that the bladder temperature was unable to be measured due to the disconnection of lead wire.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Received 1 extension cord.Visual inspection noted using a multimeter, the cord was tested for and found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath (119118 lot ngevz327) the cord was then attached to a kilo device and the temperature displayed 37.3 celsius, similar to the thermometer reading.The photo sample was returned and could not be evaluated for the reported failure.The sample meets the specification "plug and jack must be firmly secured to wire." a dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling 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 inspected.

• Brand Name: BARD® EXTENSION CABLE
• Common Device Name: BARD® EXTENSION CABLE
• 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: 17780101
• Report Number: 1018233-2023-06900
• Device Sequence Number: 6576306
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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): 12/05/2023

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 Catalogue Number: 153622
• Device Lot Number: BMHP0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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