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

Catalog Number	0601760
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fitting Problem (2183); Defective Component (2292); Material Deformation (2976); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during chronic catheter repair procedure, there is a clear piece present around the metal lumen stents that allegedly would not connect to the patient's line.It was further reported that when tried to connect and flush and draw the pieces would not fit together and would leak bloody saline and draw in air bubbles.Reportedly, the repair kit was allegedly deformed.The repair kit was removed and replaced.There was no reported patient 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 device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2025) 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one 7fr d/l hickman repair kit catheter was returned for evaluation.Visual, microscopic, functional and tactile evaluations were performed on the returned device.The metal luers were exposed at the distal end of the catheter.What appeared to be excessive adhesive, was noted on the proximal portion of the distal end of the catheter.The stents were able to slide in and out at the distal end of the repair kit.Upon dimensional observation, the length of the stents were noted to be out of the specification.Manufacturing site evaluation states that the catheter had excess of adhesive.Therefore the investigation is confirmed for the reported fitting problem, leak, air bubble issues and the identified defective component issue.However the investigation is unconfirmed for the reported deformation issue as no evidence of deformation was noted upon sample evaluation.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 during chronic catheter repair procedure, there is a clear piece present around the metal lumen stents that allegedly would not connect to the patient's line.It was further reported that when tried to connect and flush and draw the pieces would not fit together and would leak bloody saline and draw in air bubbles.Reportedly, the repair kit was allegedly deformed.The repair kit was removed and replaced.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER PEDIATRIC, DUAL-LUMEN REPAIR KIT, 7F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 20047650
• Report Number: 3006260740-2024-04663
• Device Sequence Number: 15437193
• Product Code: LJS
• UDI-Device Identifier: 00801741036484
• UDI-Public: (01)00801741036484(11)220528(17)250131(10)REGQ4006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 01/31/2025
• Device Catalogue Number: 0601760
• Device Lot Number: REGQ4006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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 Age: 12 YR
• Patient Sex: Male