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

Catalog Number	0659230
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2024
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 is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2025) 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the tunneler had allegedly broken while pulling through the catheter in the soft tissue.It was further reported that a piece of the tunneler was allegedly not retrievable after surgery and was still in the patient.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 tunneler with a loaded protective sheath segment was received for evaluation.Gross, visual, microscopic and functional testing were performed.A bend was noted on the tunneler body.The protective sheath loaded on the tunneler was noted to have a circumferential break.The edges of the complete circumferential break on the proximal end of the loaded protective sheath were noted to be jagged.The surface was noted to be granular with residue throughout.One electronic photo was provided for review.Therefore, the investigation is confirmed for the reported tunneler sheath broken and identified tunneler bent issue.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: b5, d4 (expiration date: 08/2025), g3, h6 (device).H11: h6 (method, 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
It was reported that during a chronic catheter placement procedure, the tunneler was allegedly had broken while pulling through the catheter in soft tissue.It was further reported that the piece of the tunneler was not retrievable after surgery and is still in the patient.Reportedly, catheter was removed, and the procedure was completed using another device.The patient is reported to be stable now.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the tunneler was allegedly had broken while pulling through the catheter in soft tissue.It was further reported that the piece of the tunneler was not retrievable after surgery and is still in the patient.Reportedly, the catheter was removed and the procedure was completed using another device.The patient is reported to be stable now.
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 tunneler with a loaded protective sheath segment was received for evaluation.Along with the sample, one photo was provided for review.Gross visual, microscopic and functional testing were performed on the returned sample.A bend was noted on the tunneler body.The protective sheath loaded on the tunneler was noted to have a circumferential break.The edges of the complete circumferential break on the proximal end of the loaded protective sheath were noted to be jagged.The surface was noted to be granular with residue throughout.Therefore, the investigation is confirmed for the reported tunneler sheath broken issue.However, the investigation is inconclusive for the reported difficult to remove issue as the exact circumstance at the time of the reported event was unknown.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.

• 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: 19317936
• Report Number: 3006260740-2024-02351
• Device Sequence Number: 15365900
• Product Code: LJS
• UDI-Device Identifier: 00801741036569
• UDI-Public: (01)00801741036569(17)250831(10)REHW3385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 0659230
• Device Lot Number: REHW3385
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 03/19/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/26/2024; 03/21/2025
• 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