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

Model Number 153622

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

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 packaging of the temperature sensing foley catheter extension cord was half empty.Per follow up information received via ibc on 06jul2022, stated that the packaging of the product was half empty indicating that the package was opened.

Manufacturer Narrative

The reported event is inconclusive due to poor sample condition.Photo samples were provided which show the packaging partially opened.The extension cable was returned partially open in the original packaging.The device packaging was observed to be partially opened on one end along the perforated lines.The other end of the packaging was observed to be unsealed and taped closed (possibly by the user).Though one end of the packaging was unsealed, this event will be inconclusive as it is unknown how the packaging was received by the customer.No visual defects were noted on the extension cable.A potential root cause for this event could be, "aggressive handling".As no patient involvement was reported the device was not used, though it is intended for treatment or diagnostic purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.Correction: d.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.

Event Description

It was reported that the packaging of the temperature sensing foley catheter extension cord was half empty.Per follow up information received via ibc on 06jul2022, stated that the packaging of the product was half empty indicating that the package was opened.

• Brand Name: BARD® EXTENSION CABLE
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15015214
• MDR Text Key: 295897260
• Report Number: 1018233-2022-05448
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045875
• UDI-Public: (01)00801741045875
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

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
• Device Lot Number: BMGR0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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