MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 7F; CHRONIC CATHETERS

Catalog Number 0600570

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260)

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

Event Date 06/12/2023

Event Type  malfunction  

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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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 : device pending return.

Event Description

It was reported that five months and twenty one days post chronic catheter placement, when attempting to flush and heparinize the white lumen of the catheter, a snap was heard, followed by evidence that there was allegedly a crack in the line and saline was allegedly leaking from the tubing.It was further reported that the line was allegedly difficult to flush.Furthermore, a break was identified in the line.Reportedly, the line was repaired.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 7fr bard d/l catheter was received for evaluation and three photos were provided for review.Visual, microscopic, tactile and functional evaluations were performed.A c-shape brake was noted on the white luer extension leg, proximal to the clamping sleeve.Upon infusion of the white luer, a leak from the c-shaped split was observed from the extension leg.The investigation is unconfirmed for the reported fracture issue as the specific damage such as burst was identified and confirmed upon investigation.The investigation is also confirmed for the reported leak issue.However the investigation is inconclusive for the reported difficult to flush issue as the exact circumstance at the time of the event reported was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device).H11: h6 (method, result, conclusion).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 five months and twenty one days post chronic catheter placement, when attempting to flush and heparinize the white lumen of the catheter, a snap was heard, followed by evidence that there was allegedly a crack in the line and saline was allegedly leaking from the tubing.It was further reported that the line was allegedly difficult to flush.Furthermore, a break was identified in the line.Reportedly, the line was repaired.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 7F
• Type of Device: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17562426
• MDR Text Key: 321812251
• Report Number: 3006260740-2023-03575
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0600570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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