MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER HICKMAN 8 FR SL; CHRONIC CATHETERS

Catalog Number	0805815
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 08/2025).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.
Event or Problem Description
It was reported that two months and eighteen days post a chronic catheter placement, the cuff on the catheter allegedly came off while removing the catheter.It was further reported that the cuff was unable to be retrieved.The current status of the patient is unknown.
Event or Problem Description
It was reported that two months and eighteen days post a chronic catheter placement, the cuff on the catheter allegedly came off while removing the catheter.It was further reported that the cuff was separated from catheter within the tunneled tract.Reportedly the cuff was unable to retrieve from the patient.Patient underwent tract exploration.The current status of the patient was discharged with retained cuff.
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 not returned.The manufacturing site evaluation states that the tissue cuff was not placed in the catheter body, no cuff adhesive was observed on the catheter section.It is confirmed that the cuff has detached from the catheter shaft.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 issue as the exact clinical condition cannot be reproduced under laboratory condition.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: g3 h11: d4 (unique identifier (udi) #), h6 (method, result).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.

• Brand Name: POWER HICKMAN 8 FR SL
• 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: 19998154
• Report Number: 3006260740-2024-04521
• Device Sequence Number: 19914818
• 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: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/16/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White