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

Catalog Number	0609190
Medical Device Problem Codes	Component Missing (2306); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f: the information provide 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 preparation for a chronic catheter placement procedure, the catheter was allegedly received without label.There was no patient contact.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported label missing issue as no objective evidence was provided for review.The definitive root cause could not be determined based upon 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 provide 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 prior to a chronic catheter placement procedure, the catheter was allegedly received without label.There was no patient contact.
Additional Manufacturer Narrative
H11: 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 the partial view of a cardboard carton which contains one shipping label and other two labels.The investigation is inconclusive for the reported label missing issue as the photo evidence provided is not sufficient to confirm the reported event.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.G2, g3, h6 (component, method).Section a through f: the information provide 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 a chronic catheter placement procedure using hickman catheter.Prior to procedure, the catheter was allegedly received without label.There was no patient contact.
Event or Problem Description
A patient underwent a chronic catheter placement procedure using hickman catheter.Prior to procedure, the catheter was allegedly received without label.There was no patient contact.
Additional Manufacturer Narrative
H11: 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 the partial view of a cardboard carton which contains one shipping label and other two labels.The investigation is inconclusive for the reported missing information and missing component issues as the photo evidence provided is not sufficient to confirm the reported event.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.G3, h6 (device).Section a through f: the information provide 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 a chronic catheter placement procedure using hickman catheter.Prior to procedure, the catheter was allegedly received without label.There was no patient contact.
Additional Manufacturer Narrative
H11: 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, two photos were provided for review.The first photo shows the partial view of a cardboard box which has a sticker containing the shipping details.The second photo shows an unsealed cardboard box which contains one product pouch inside and another product pouch kept outside.Both tyvek label is noted to be blank without any information.The manufacturing evaluation states that the visual inspection of the image (1) showed a cardboard box which has a sticker containing the shipping details, and it was observed that the visible label on the right side of the box indicated a trifusion catheter 19 cm, and that there were 7 units inside.Inspection of the image (2) observed an individual package of the trifusion catheter, and no abnormality was observed in the tyvek of the tray.A closer view showed that there was a second tray inside the cardboard box.However, the 2 trays visible in this image were not contained within their cartons.Therefore, the investigation is confirmed for the reported missing information and missing carton issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon 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.G3, h6 (result).Section a through f: the information provide 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 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: 21013102
• Report Number: 3006260740-2024-07745
• Device Sequence Number: 9004559
• Product Code: LJS
• UDI-Device Identifier: 00801741036521
• UDI-Public: (01)00801741036521
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/17/2025

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: 0609190
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 04/04/2025; 09/25/2025; 10/17/2025; 11/17/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 04/08/2025; 09/29/2025; 10/24/2025; 11/19/2025
• 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
• Patient Sex: Unknown