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

Model Number 153622

Device Problem No Display/Image (1183)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

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 contact of relay cable of temperature sensing foley catheter was bad.Per follow up on 03nov2020, the customer was complained about sensing problem of cable in the temperature sensing foley catheter.

Event Description

It was reported that the contact of relay cable of temperature sensing foley catheter was bad.Per follow up on (b)(6) 2020, the customer was complained about sensing problem of cable in the temperature sensing foley catheter.

Manufacturer Narrative

The reported event was unconfirmed because the device meets specifications.The device did not fail to meet relevant specifications.The product was used for diagnostic purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.The lot number was unknown; therefore, the device history record could not be reviewed.As the reported event was unconfirmed a labeling review was not required.H11:section a through f - the information provided by bd represents all of 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
• Type of Device: BARD EXTENSION CABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10871867
• MDR Text Key: 217323246
• Report Number: 1018233-2020-21085
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 153622
• Device Catalogue Number: 153622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other