MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN SINGLE LUMEN CATHETERS; CHRONIC CATHETERS

Catalog Number	UNK HICKMAN S/L CATHETERS
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 port placement procedure, when positive pressure was applied, a part of the catheter was allegedly found to be expanded.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement procedure, when positive pressure was applied, a part of the catheter was allegedly found to be expanded.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one broviac s/l catheter in three segments was returned for evaluation.Visual, microscopic, tactile and functional evaone broviac s/l catheter in two segments were received for evaluation.Microscopic, visual, tactile and functional testing were performed on the returned device.A complete circumferential break was noted at the distal end of the catheter.The edges of the complete circumferential break on the distal end of the catheter were noted to be uneven.The surface was noted to be glossy with striations throughout.Complete circumferential breaks were noted to both ends of the distal catheter segment.The edges on the proximal end of the distal catheter segment were noted to be uneven.The surface was noted to be glossy with striations throughout.The edges of the on the distal end of the distal catheter segment were noted to be uneven.The surface was noted to be glossy with striations throughout.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing to observe for leaks and ballooning, no issues were observed.Therefore, the investigation is unconfirmed for the reported catheter expansion issue.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.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.

• Brand Name: HICKMAN SINGLE LUMEN CATHETERS
• 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: 19981655
• Report Number: 3006260740-2024-04457
• Device Sequence Number: 11474835
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• 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): 10/29/2024

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: UNK HICKMAN S/L CATHETERS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/04/2024
• 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