MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN,12F; CHRONIC CATHETERS

Catalog Number	0600620
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Suction Problem (2170)
Health Effect - Clinical Codes	Bacterial Infection (1735); Sepsis (2067)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ten months and ten days post a port placement, when flushed the lumen it was noticed that saline was leaking out at an obvious split in the lumen.It was further reported that the patient had blood cultures (acinetobacter nosocomialis) and exposed to external contamination.Reportedly, patient had symptoms of sepsis including fever and rigors.Blood cultures from the hickman showed gram positive cocci and antibiotics were given.The port was removed.The current status of the patient was unknown.
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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 9fr hickman d/l catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A s-shaped split was noted on the white luer extension leg, proximal to the clamping sleeve.The catheter felt abnormally elastic when it was gently pulled and stretched throughout.Upon infusion, a leak was observed from the s-shaped split on the extension leg was observed.No water was observed exiting the distal end.Aspiration was attempted and was successful as water fully returned within the attached in-house syringe.Therefore, the investigation is confirmed for the reported fracture, leak and identified burst issue.However the investigation is inconclusive for the reported aspiration difficulty and flushing issue as the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.Furthermore, however, clinical conditions alleged in the complaint cannot be confirmed.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.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 or Problem Description
It was reported that ten months and ten days post a port placement, when flushed the lumen it was noticed that saline was leaking out at an obvious split in the lumen.It was further reported that the patient had blood cultures (acinetobacter nosocomialis) and exposed to external contamination.Reportedly, patient had symptoms of sepsis including fever and rigors.Blood cultures from the hickman showed gram positive cocci and antibiotics were given.Reportedly, the port was removed.The current status of the patient was unknown.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• 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 REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20503247
• Report Number: 3006260740-2024-06117
• Device Sequence Number: 8445080
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0600620
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown