MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; 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	03/15/2023
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that "port accessed by homecare on (b)(6) 2023, admitted on (b)(6), patient had ivf with bicarb infusing into huber needle.On (b)(6) 2023 1400 rn noticed huber needle tubing line broken, noticed blood in tubing, and red and clear fluid in valguard; needle de-accessed from port; hole is noted in tubing right before connecting to the luer blue connection piece.Blood cultures drawn on 3/16 10am negative.".
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 break in the infusion set tubing was confirmed but the cause is unknown.A single photograph of a damaged infusion set was returned for evaluation.The implicated product was a 20g x 1¿ powerloc max safety infusion set.The photograph was focused on the proximal end of the device.Red residual material was seen within the infusion set tubing and luer adaptor, indicating that the device had been used.A small semi-circumferential split was seen in the tubing, directly distal of the luer adaptor.Microscopic observation and tactile evaluation could not be conducted without the physical sample.The observable features on the submitted photograph did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors could include tensile (pulling) damage, material fatigue, or damage from a sharp instrument.
Event or Problem Description
It was reported by the customer that "port accessed by homecare on (b)(6) 2023, admitted on (b)(6) , patient had ivf with bicarb infusing into huber needle.On (b)(6) 23 1400 rn noticed huber needle tubing line broken, noticed blood in tubing, and red and clear fluid in valguard; needle de-accessed from port; hole is noted in tubing right before connecting to the luer blue connection piece.Blood cultures drawn on (b)(6) 10am negative.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16843675
• Report Number: 3006260740-2023-01606
• Device Sequence Number: 15159380
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 04/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 0142010
• Device Lot Number: ASGRF064
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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