MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER PEDIATRIC, DUAL-LUMEN REPAIR KIT, 7F; PORT AND CATHETER ACCESSORIES

Catalog Number	0601760
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Device Damaged Prior to Use (2284); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
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 device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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 prior to a chronic catheter repair kit procedure, the device was allegedly damaged when opened.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 7f broviac d/l repair kit catheter was returned for evaluation, and two photos were provided for review.The metal stems were noted to be exposed at the distal end of the catheter.Adhesive material was noted around the proximal portions of the metal stems.The large metal stem moved from place when gently pulled/pushed.The manufacturing site evaluation states, visual inspection of the images showed that the metal stems were observed to be exposed at the distal end of the catheter.Adhesive material was observed around the proximal portions of the metal stems.A closer look revealed that the longer stent had separated from the catheter, residues of use were observed through the sample.Therefore, the investigation is inconclusive for the reported device damaged prior to use as the exact circumstance at the time of the reported event was unknown.However, it is unconfirmed for the reported material integrity issue as more specific damages fracture and material separation issues were identified during investigation.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G2, d4 (unique identifier (udi) #), g3, h4, h6 (device, component, method, result, conclusion).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 repair kit procedure, the device was allegedly damaged when opened.The procedure was completed using another device.There was no patient contact.

• Brand Name: HICKMAN CV CATHETER PEDIATRIC, DUAL-LUMEN REPAIR KIT, 7F
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: 21503282
• Report Number: 3006260740-2025-01138
• Device Sequence Number: 8020968
• Product Code: LJS
• UDI-Device Identifier: 00801741036484
• UDI-Public: (01)00801741036484(11)230531(17)260228(10)REHQ4069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/07/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 0601760
• Device Lot Number: REHQ4069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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