MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that over the past few weeks there have been multiple failures of the bd power loc max mediport needle.The failures occur in the tubing causing a leak.Results in both drug loss and blood exposure.No other information was provided.It was reported this occurred with 3 devices.This report addresses all 3 devices.
Additional Manufacturer Narrative
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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that over the past few weeks there have been multiple failures of the bd power loc max mediport needle.The failures occur in the tubing causing a leak.Results in both drug loss and blood exposure.No other information was provided.It was reported this occurred with 3 devices.This report addresses all 3 devices.
Additional Manufacturer Narrative
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.The initial complaint was submitted with (b)(6) 2024 as the date of awareness.After further review, it was determined the date of awareness for this event is 20 september 2024.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Additional Manufacturer Narrative
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.The date of awareness for this complaint is september 20, 2024.The date of occurrence for this complaint is september 19, 2024.The complaint of leak was confirmed.The product returned for evaluation was one 20g powerloc max infusion set w/y-site.The returned product sample was evaluated and the following observations were made: ¿ a tear in the extension tube was observed at the interface of the y-site the fracture surfaces of the damage contained striation-like patterns which were indicative of flexural fatigue based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that over the past few weeks there have been multiple failures of the bd power loc max mediport needle.The failures occur in the tubing causing a leak.Results in both drug loss and blood exposure.No other information was provided.It was reported this occurred with 3 devices.This report addresses all 3 devices.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20482320
• Report Number: 3006260740-2024-05997
• Device Sequence Number: 4095606
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374(11)231216(17)260715(10)ASHUFC077
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 07/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 0132075
• Device Lot Number: ASHUFC077
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 01/28/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/26/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: Other
• Patient Sex: Unknown