MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0142275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that tubing breakages.¾ in pac needle broken at hub near cap, had to reaccess port in the middle of the night d/t tubing breaking requiring a replacement.No other information provided, at this time.A specific number of affected devices or patients was not provided by the complainant.
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 complaint of a leak was confirmed.The product returned for evaluation was a 22ga powerloc infusion set without a y-site.The returned product samples were evaluated and the following observations were made: a complete break in the extension tube was confirmed and occurred at the interface of the proximal luer adapter.The fracture surfaces of the damage contained striation-like patterns and radiating tear marks, 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 may have contributed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that tubing breakages.¾ in pac needle broken at hub near cap, had to reaccess port in the middle of the night d/t tubing breaking requiring a replacement.No other information provided, at this time.A specific number of affected devices or patients was not provided by the complainant.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G 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 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20767943
• Report Number: 3006260740-2024-06975
• Device Sequence Number: 8533057
• Product Code: FPA
• UDI-Device Identifier: 00801741047497
• UDI-Public: (01)00801741047497
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 03/11/2025

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 Catalogue Number: 0142275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 03/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown