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

Catalog Number UNK HICKMAN D/L CATHETERS

Device Problems Fracture (1260); Stretched (1601); Material Protrusion/Extrusion (2979)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

It was reported that thirteen days post chronic catheter placement procedure, the catheter allegedly had broken.It was further reported that the catheter allegedly had ballooning.Reportedly the catheter was repaired.There was no reported patient injury.

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.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 pending return.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one hickman d/l catheter was returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.However, striations were noted throughout the surface.The investigation is confirmed for the reported stretched, protrusion and catheter fracture, as a compound split was noted approximately 7.2cm from the distal end of the luer.The edges of the compound split were observed to be sharp and smooth.A definitive root cause could not be determined based upon the 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.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 thirteen days post chronic catheter placement procedure, the catheter allegedly had broken.It was further reported that the catheter allegedly had ballooning.Reportedly the catheter was repaired.There was no reported patient injury.

• Brand Name: HICKMAN DUAL LUMEN CATHETERS
• Type of Device: CHRONIC CATHETER
• 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: 15189463
• MDR Text Key: 305262753
• Report Number: 3006260740-2022-03101
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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 Catalogue Number: UNK HICKMAN D/L CATHETERS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 10/26/2022
• 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
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Black Or African American