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

Catalog Number	0609230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2025).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 sometime post a chronic catheter placement, the hole was allegedly found on the catheter just distal to the cuff.It was further reported that fluid leak was allegedly found from the insertion site after flushing.After the removal of the line, all the three lumens were allegedly leaked from a spot in the catheter just distal to the cuff.It was also reported that crack was allegedly found after the line was removed.Furthermore, the patient experienced extravasation.However, the patient was treated with medication.Reportedly, the catheter was pulled and replaced.The current status of the patient is unknown.
Additional 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 23cm trifusion t/l catheter was returned for sample evaluation.Functional, gross, visual, tactile and microscopic visual evaluations were performed.The complaint sample was returned with all clamps disengaged.Suture wire was noted tied to the catheter and bifurcate.A split was noted on distal end of the tissue cuff.Upon infusion in white luer, a leak from the split was noted, aspiration was attempted and was unsuccessful.Infusion and aspiration were patent to blue luer and red luer.No other anomalies were observed.Therefore, the investigation is confirmed for the reported fracture and fluid leak issue.However, the investigation is inconclusive for the reported material hole as no material hole were noted in sample analysis.Furthermore, 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.H10: d4 (expiration date: 05/2025).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 sometime post a chronic catheter placement, the hole was allegedly found on the catheter just distal to the cuff.It was further reported that fluid leak was allegedly found from the insertion site after flushing.After the removal of the line, all the three lumens were allegedly leaked from a spot in the catheter just distal to the cuff.It was also reported that crack was allegedly found after the line was removed.Furthermore, the patient experienced extravasation.However, the patient was treated with medication.Reportedly, the catheter was pulled and replaced.The current status of the patient is unknown.

• Brand Name: HICKMAN TRIFUSION CV CATHETER, TRIPLE-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: 18863324
• Report Number: 3006260740-2024-00988
• Device Sequence Number: 3307192
• Product Code: LJS
• UDI-Device Identifier: 00801741036538
• UDI-Public: (01)00801741036538
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 0609230
• Device Lot Number: REHT2739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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