MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0142010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer the patient accessed with bard powerloc max at the hospital.Port was accessed with this needle on (b)(6) 2023 with multiple ivs/chemo infusing through it until (b)(6) 2023.At -115am rn noticed patient line with hole and bleeding.Hole is in the port needle tubing right before it connects to the luer blue connection port.Blood cultures were drawn and 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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a leaking infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 20ga infusion set.The depicted portion of the device included the luer adapter, clamp and a portion of extension tubing.The needle housing was not visible, so the infusion set type could not be identified.Blood residues was visible on the clamp and within the extension tubing.A partially circumferential split was observed at the luer/tubing joint.The split edges appeared irregular.Infusion set damage was visible within the provided photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer the patient accessed with bard powerloc max at the hospital.Port was accessed with this needle on 2/15/23 with multiple ivs/chemo infusing through it until (b)(6) 23.At -115am rn noticed patient line with hole and bleeding.Hole is in the port needle tubing right before it connects to the luer blue connection port.Blood cultures were drawn and 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16792403
• Report Number: 3006260740-2023-01506
• Device Sequence Number: 5781170
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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 Catalogue Number: 0142010
• Device Lot Number: ASGRF064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• 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: 07/31/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 08/03/2023
• 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