MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN D/L CATHETERS; CHRONIC CATHETERS

Catalog Number UNK HICKMAN D/L CATHETERS

Device Problems Material Too Rigid or Stiff (1544); Expiration Date Error (2528)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that some time post dialysis catheter placement, it was noted that the device that was placed in the patient had passed the expiration date and the catheter feels harder and more brittle.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.

Event Description

It was reported that some time post dialysis catheter placement, it was noted that the device that was placed in the patient had passed the expiration date and the catheter feels harder and more brittle.There was no reported patient injury.

Event Description

It was reported that some time post dialysis catheter placement, the catheter was allegedly hard and brittle.It was further reported that the health care provider decided to used expired product for this procedure.There was no reported patient injury.

Manufacturer Narrative

H10: corrections were made to the country of event.Additionally after further review of the reported issue, it has been determined that this event was reported as a malfunction in error.The physician made the decision to use the product beyond the labeled expiration date and reportedly the line looked and is functioning fine.There was no reported clinical impact to the patient, but it was the mother opinion that the line felt abnormal.The purpose of this report is to identify the error in previously classifying this event as a malfunction reportable event.H10: g4 h11: b5, e1 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.Device not returned.

• Brand Name: HICKMAN D/L CATHETERS
• Type of Device: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10783401
• MDR Text Key: 214519207
• Report Number: 3006260740-2020-20358
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

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 Catalogue Number: UNK HICKMAN D/L CATHETERS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 12/02/2020
• Supplement Dates FDA Received: 11/09/2020; 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR