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

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/15/2023
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 customer that patient presented for ambulatory fluorouracil pump disconnect.Patient receives folfiri + cetuximab.Patient had visible drug leaking (white powder) around upper lumen cap.Microclave luer lock connector.No visible drug on patient's clothing or skin.Patient accessed on (b)(6) 2023.Additional information received 26 sep 2023: it was reported there was no harm to the patient.Patient received medication but could have been exposed to the chemo agent in results of the notable white powder.
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 applicable information, the following was concluded: 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.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.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by customer that patient presented for ambulatory fluorouracil pump disconnect.Patient receives folfiri + cetuximab.Patient had visible drug leaking (white powder) around upper lumen cap.Microclave luer lock connector.No visible drug on patient's clothing or skin.Patient accessed on (b)(6) 2023.Additional information received on 26 sep 2023: it was reported there was no harm to the patient.Patient received medication but could have been exposed to the chemo agent in results of the notable white powder.

• 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 UT 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17872892
• Report Number: 3006260740-2023-04487
• Device Sequence Number: 20207075
• 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
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 0671910
• Device Lot Number: ASGYFC003
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: 59 YR
• Patient Sex: Male