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

Catalog Number	0805815
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometimes post a catheter placement, the tip of the catheter allegedly broke off.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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025).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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one luer cap was returned for sample evaluation.Visual evaluation was performed.Functional testing was not performed due to the condition of the sample.Catheter hub was noted to be loaded to the distal end of the luer cap.The segments fell off the luer when examined and reflected material separation.Fracture was noted and luer was broken into multiple peace.Therefore, the investigation is confirmed for reported fracture and material separation issue.However, the investigation is inconclusive for the reported fluid leak issue as no objective evidence was found from 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.H10: b5, d4 (expiration date: 06/2025), g3, h6 (device) h11: b3, h6 (method, 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.H3 other text : see h10.
Event or Problem Description
It was reported that sometimes post chronic catheter placement procedure, tip allegedly broke off.It was further reported that the device allegedly had leak when flushing.Reportedly, the line was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that sometimes post chronic catheter placement procedure, tip allegedly broke off.It was further reported that the device allegedly had leak when flushing.Reportedly, the line was removed and replaced.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: one luer cap was returned for sample evaluation.Visual evaluation was performed.Functional testing was not performed due to the condition of the sample.Catheter hub was noted to be loaded to the distal end of the luer cap.The segments fell off the luer when examined and reflected material separation.Fracture was noted and luer was broken into multiple peace and may resulting the leak.Therefore, the investigation is confirmed for reported fracture, leak and material separation issue.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: d4 (expiration date: 06/2025).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: 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: 18417593
• Report Number: 3006260740-2023-05927
• Device Sequence Number: 17849340
• Product Code: LJS
• UDI-Device Identifier: 00801741036675
• UDI-Public: (01)00801741036675
• 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
• Device Explanted Year: 2023
• 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): 08/01/2024

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: 0805815
• Device Lot Number: REHW3347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 03/28/2024; 08/01/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 04/03/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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