MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERHICKMAN CV CATHETER, POLYURETHANE SINGLE-LUMEN, 9.5F; CHRONIC CATHETERS

Catalog Number	0805815
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the catheter was allegedly removed while the cuff remained intact underneath the tunneled portion of the skin.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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/205).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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 8fr power hickman s/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The tissue cuff appeared to be detached from the catheter and was returned.Manufacturing site evaluation states that cuff was detached from the catheter, no cuff adhesive was observed on the catheter portion.Therefore the investigation is confirmed for the reported cuff detachment from the catheter issue.However the investigation is inconclusive for the reported difficulty in retrieving the cuff and cuff entrapment in patient issues as the exact clinical condition cannot be reproduced under laboratory condition.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, h6 (device, method).H11: d4 (unique identifier (udi) #), h6 (result, conclusion).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 a chronic catheter placement procedure, the catheter was allegedly removed while the cuff remained intact underneath the tunneled portion of the skin.It was further reported that the cuff has been removed from the catheter and was noted to be stuck in the patient's skin.Reportedly, the cuff needed to be dissected out of the patient.There was no reported patient injury.

• Brand Name: POWERHICKMAN CV CATHETER, POLYURETHANE SINGLE-LUMEN, 9.5F
• 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: 19969394
• Report Number: 3006260740-2024-04415
• Device Sequence Number: 8810161
• Product Code: LJS
• UDI-Device Identifier: 00801741036675
• UDI-Public: (01)00801741036675(11)231206(17)250831(10)REHY0721
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• 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
• Report Date (Section B): 08/30/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 0805815
• Device Lot Number: REHY0721
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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