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

Model Number	153622
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
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.H3 other text: the device was not returned.
Event or Problem Description
It was reported that temperature was not displayed properly.The temperature displayed on the monitor was not stable.There are 4 others with the same manufacturing number, and they are also red and black processed.
Event or Problem Description
It was reported that temperature was not displayed properly.The temperature displayed on the monitor was not stable.There are 4 others with the same manufacturing number, and they are also red and black processed.As per the follow up information received via ibc on 19jun2023, there were 5 samples from the same lot were of the same issue.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.Though a specific cause cannot be determined, potential root causes for this failure are "wrong dimensions on competitors or our own connector" or "user damaged pins when inserting connector".The dhr review did not indicate any manufacturing nonconformance that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the label currently states " for use with bard temperature-sensing products and accessories"." 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.

• Brand Name: BARD® EXTENSION CABLE
• Common Device Name: EXTENSION CORD
• 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: 17260507
• Report Number: 1018233-2023-04871
• Device Sequence Number: 15445360
• 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): 10/16/2023

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: 153622
• Device Catalogue Number: 153622
• Device Lot Number: BMHP0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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