MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTABLE INFUSION SET 20G X 1.0IN; 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	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patient port accessed w/20 g x 1¿ bard huber needle, had a levaquin infusing fluid leaking from tubing, noted 1 in huber needle cracked, port accessed on (b)(6) 2021.Pt refused val-guard; need to use teddy bears when line not infusing.Wasn¿t able to send until cultures were negative.".
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect/invalid.
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed and the cause is currently under investigation.The product returned for evaluation was two 20ga x 1" powerloc max safety infsuion sets.The returned product samples were evaluated and the following observations were made: the first sample exhibited a fracture at the luer/tubing joint.The fracture surfaces of the damage contained striation-like patterns, radiating tear marks and material buckling 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.The second sample did not exhibit leakage or damage and may have been returned as a reference sample.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "patient port accessed w/20 g x 1¿ bard huber needle, had a levaquin infusing fluid leaking from tubing, noted 1 in huber needle cracked, port accessed on (b)(6) 2021.Pt refused val-guard; need to use teddy bears when line not infusing.Wasn¿t able to send until cultures were negative.".

• Brand Name: POWERLOC MAX POWER-INJECTABLE INFUSION SET 20G X 1.0IN
• 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; parque industrial colonial; salt lake city 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13308959
• Report Number: 3006260740-2022-00043
• Device Sequence Number: 14693661
• Product Code: FPA
• UDI-Device Identifier: 00801741089169
• UDI-Public: (01)00801741089169
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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 Model Number: N/A
• Device Catalogue Number: 0142010
• Device Lot Number: AS7R061-INVALID
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/22/2022
• 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 Age: 2 YR
• Patient Sex: Female
• Patient Weight: 12 KG