MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F; CHRONIC CATHETERS

Catalog Number	0600560
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional 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 device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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 or Problem Description
It was reported that eleven months and one day post a chronic catheter placement, the white adaptor end was allegedly separated into two pieces.It was further reported that the two pieces were glued together but it was unsuccessful.Reportedly, the device was repaired.There was no reported patient injury.
Event or Problem Description
It was reported that eleven months and one day post a chronic catheter placement, the white adaptor end was allegedly separated into two pieces.It was further reported that the two pieces were glued together but it was unsuccessful.Reportedly, the device was repaired.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.One photo was provided for review.The photo shows a complete break of the crimp collar and separated from the luer adapter.Therefore, the investigation is confirmed for the reported white adaptor end allegedly separated into two pieces issues.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 (method).H11: h6 (result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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 or Problem Description
A patient underwent for a chronic catheter placement procedure using hickman cv catheter, single-lumen, 9.6f.It was reported that eleven months and one day post a chronic catheter placement, the white adaptor end was allegedly separated into two pieces.It was further reported that the two pieces were glued together, but it was unsuccessful.Reportedly, the device was repaired.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: although the physical device was not returned for evaluation, one photo was provided for review.The photo shows the partial view of catheter extension leg.The white adaptor end segment was noted to be detached from the hub.No other visible break was noted.The investigation is confirmed for the identified detachment of device or device component issue.However, the investigation is inconclusive for reported fracture and material separation issues as no break was visible in photo provided and we are unsure if the break exists in other part of the device, only partial view was visible.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.B5, g3, h6 (device) section a through f: the information provided by bd represents all 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.

• Brand Name: HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F
• Common Device Name: 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: 19641626
• Report Number: 3006260740-2024-03400
• Device Sequence Number: 8609930
• Product Code: LJS
• UDI-Device Identifier: 00801741051845
• UDI-Public: (01)00801741051845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0600560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 05/11/2026
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/21/2024; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown