MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "i have had two more leaking hubers in the same place this week." no other information was provided.This report addresses the first device.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) review is not possible, as no manufacturing lot number has been 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.
Event or Problem Description
It was reported by the customer that "i have had two more leaking hubers in the same place this week." no other information was provided.This report addresses the first 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 complaint of a leak in the needle housing was unconfirmed as the alleged issue could not be reproduced.The product returned for evaluation was a 20 g x 1¿ w/y-site powerloc max infusion set.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.The sample was functionally tested for leakage by forceful infusion with a laboratory syringe and water combination, and the device did not exhibit leakage through the system.The reported complaint issue will be included as part of ongoing trending and monitoring for potentially similar events.
Event or Problem Description
It was reported by the customer that "i have had two more leaking hubers in the same place this week." no other information was provided.This report addresses the first device.

• Brand Name: POWERLOC MAX SAFETY INFUSION SET 20G X 1.0 INCH 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16371768
• Report Number: 3006260740-2023-00430
• Device Sequence Number: 20522517
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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 Model Number: N/A
• Device Catalogue Number: CPA00052
• Device Lot Number: UNKNOWN
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 07/12/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/12/2023; 07/20/2023
• 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