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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that no patient harm, but patient was exposed to chemo leak and was in public when the leak occurred.The connector came off of the tubing exposing the lumen.Patient called, advised to turn off and come in to be evaluated the same day.A new cassette was given the next day to patient to receive medication.It was stated there was a delay in care.No other information was provided.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
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 is unconfirmed and could not be reproduced.One 19g x 1" powerloc infusion set was returned for evaluation.The sample did not show signs of damage to the luers or tubing and was within specification of all parts.The sample was pressurized and a leak was not observed.Due to the complaint being unable to be reproduced, this complaint is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that no patient harm, but patient was exposed to chemo leak and was in public when the leak occurred.The connector came off of the tubing exposing the lumen.Patient called, advised to turn off and come in to be evaluated the same day.A new cassette was given the next day to patient to receive medication.It was stated there was a delay in care.No other information was provided.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18285617
• Report Number: 3006260740-2023-05575
• Device Sequence Number: 20544705
• 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): 01/24/2024

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 Model Number: N/A
• Device Catalogue Number: 0671910
• Device Lot Number: ASHTFC025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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