MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F; CHRONIC CATHETERS

Model Number 0600650

Device Problems Burst Container or Vessel (1074); Fracture (1260)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2027) 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 during a chronic catheter placement procedure, the white lumen of the line allegedly fractured.It was further reported that the catheter was repaired.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one hickman t/l catheter was received for evaluation and two electronic photos were received for evaluation.The photo shows one hickman catheter and a "c"- shaped split was noted on the distal tip of the catheter.Visual, microscopic, tactile and functional tests were performed.A c-shape break was noted on the extension leg distal to the clamp and the edges of the c-shaped break were observed to be uneven.Upon infusion water was noted leaking from the c-shaped break and exiting through the distal tip.Therefore, the investigation is confirmed for the identified burst issue.However, the investigation is unconfirmed for the reported fracture issue as the more specific burst issue was identified during investigation.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 01/2027), g3, h6 (device).H11: e3, 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.H3 other text : see h10.

Event Description

It was reported that during a chronic catheter placement procedure, the white lumen of the line allegedly fractured.It was further reported that the catheter was repaired.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F
• 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: 17235452
• MDR Text Key: 318181613
• Report Number: 3006260740-2023-02708
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600650
• Device Catalogue Number: 0600650
• Device Lot Number: HUGV0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• 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