MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN REPAIR KIT, RED/WHITE, 9F; PORT AND CATHETER ACCESSORIES

Catalog Number	0601700
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
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 device has not 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 approximately three years one month and twenty one days post chronic catheter placement, upon performing the catheter repair, a metal stent segment was allegedly found to be protruding out of the catheter at an angle.Reportedly, the catheter was repaired.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 not 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: 07/2023), g3, h6 (device).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 approximately three years one month and twenty one days post chronic catheter placement, upon performing the catheter repair, a metal stent segment was allegedly found to be protruding out of the catheter at an angle.Reportedly, the catheter was repaired.There was no reported patient injury.
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: the sample was not returned for evaluation.Two electronic photos were provided for review.The photo shows the partial view of the catheter and metal segment was noted to be poking out from the catheter.Therefore, the investigation is confirmed for the reported material protrusion, device dislodgement, loss of bond and material separation.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: (expiration date: 07/2023).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 three years, one month, and twenty-one days post chronic catheter placement, upon performing the catheter repair, a metal stent segment was allegedly found to be protruding out of the catheter at an angle.Reportedly, the catheter was repaired.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN REPAIR KIT, RED/WHITE, 9F
• 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 PR 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17285042
• Report Number: 3006260740-2023-02836
• Device Sequence Number: 14208921
• Product Code: LJS
• UDI-Device Identifier: 00801741036439
• UDI-Public: (01)00801741036439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/03/2023

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: 0601700
• Device Lot Number: REFQ4513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 10/03/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 09/13/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 20 YR
• Patient Sex: Female