MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 IN WITH Y-SITE; 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	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "we have had 3 powerloc max where there is leaking from the safety mechanism on top (the piece you pull when removing the needle) with flushing once the port is accessed." no other information was provided.This report addresses the second device.
Additional Manufacturer Narrative
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.A lot history review (lhr) of regv1318 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported by the customer "we have had 3 powerloc max where there is leaking from the safety mechanism on top (the piece you pull when removing the needle) with flushing once the port is accessed." no other information was provided.This report addresses the second device.
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, applicable previous investigation(s), sample analysis, complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the needle housing was unconfirmed as the complaint could not be reproduced.The product returned for evaluation was (qty 2) 20 g x 1¿ w/y-site powerloc max infusion sets.Blood residue was seen within the tubing and needle housing, indicating use.None of these residue traces indicated a pathway for fluid to the exterior of the needle housing.Both samples were subsequently functionally tested for leakage by forceful infusion with a laboratory syringe and water combination, and neither device exhibited leakage through the system.A complaint history review found no potentially similar complaints for this product lot, and a review of the manufacture production records found no potentially related observations during production.The reported complaint issue will be included as part of ongoing trending and monitoring for potentially similar events.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 IN WITH Y-SITE
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16251038
• Report Number: 3006260740-2023-00150
• Device Sequence Number: 5351669
• Product Code: FPA
• UDI-Device Identifier: 00801741182150
• UDI-Public: (01)00801741182150
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• 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): 04/14/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CPA00052
• Device Lot Number: REGV1318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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