MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0672034
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
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 customer that when flushing to prep the needle for access, there was a leak at the base of the needle towards the wing.No other information provided, at this time.It was reported this occurred with 3 devices.This report addresses all 3 devices.
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.During follow up, customer provided 3 as the number of units they had on the shelf, not the number of units affected by the reported event.The actual affected quantity of devices for this event is 2.The complaint of leaking infusion sets is inconclusive due to the original samples not being returned for evaluation.Twelve unopened 20 ga x 0.75 in.Powerloc infusion sets were returned for evaluation.An initial visual observation of the returned products revealed each sample was returned in its unopened packaging.It was observed that samples 1, 2, 3, 4, 5, and 6 were returned with lot number asjnfc046 and part number 0672034 and samples 7, 8, 9, 10, 11 and 12 were returned with lot number asjnfc057 and part number 0672034.A functional test of infusing water into each returned infusion set using a 12 ml syringe revealed each of the twelve returned devices were patent to infusion with no observed leaks.A functional test of pressurizing each of the twelve returned infusion sets revealed no leaks throughout any of the returned devices.Because the original samples were not returned for evaluation, the complaint of leaking infusion sets is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN 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 UT 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21085725
• Report Number: 3006260740-2024-08130
• Device Sequence Number: 6831910
• Product Code: FPA
• UDI-Device Identifier: 00801741047947
• UDI-Public: (01)00801741047947(11)240420(17)270713(10)ASJNFC057
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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 Catalogue Number: 0672034
• Device Lot Number: ASJNFC057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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