MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0671910
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/09/2023
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 "we have a leak from our port needle.The patient came to have pump disconnected today on (b)(6) 23.Prior to disconnecting the nurse noticed a moderate amount of white powder and leakage from the end of the tubing site away from the needle area where the micro-clave cap and tubing connects.Patient received medication but with the white powder, patient can be exposed to chemo leakage to skin.".
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 crack in the y-site was confirmed as supplier related.The returned sample was found to exhibit the same features as a known issue, and the root cause was determined to likely be within the scope of the known issue.The returned product was a 19g x 1¿ powerloc safety infusion set.The y-site luer adaptor contained a longitudinal crack traversed from the orifice of the connector to the mold indicator.The crack in the y-site luer adaptor leaked when the sample was flushed.This event was likely related to a known supplier related issue.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that "we have a leak from our port needle.The patient came to have pump disconnected today on 10-9-23.Prior to disconnecting the nurse noticed a moderate amount of white powder and leakage from the end of the tubing site away from the needle area where the micro-clave cap and tubing connects.Patient received medication but with the white powder, patient can be exposed to chemo leakage to skin.".

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 1 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18016900
• Report Number: 3006260740-2023-04891
• Device Sequence Number: 6537681
• Product Code: FPA
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• 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
• Report Date (Section B): 01/23/2024

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: 06/06/2026
• Device Catalogue Number: 0671910
• Device Lot Number: ASGZFC029
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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 Age: 63 YR
• Patient Sex: Male