MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) review is not possible, as no manufacturing batch number has been provided by the complainant.
Event or Problem Description
It was reported by the customer "the iv team received calls from the nursing floors that the y site on this device was cracked and is leaking while in the patient.The iv team so far has had to swap out 3 devices where the y site of the device was cracked." the needle would crack and break when accessing the port of the patient.Additional information (b)(6) 2023.It was reported there was no immediate harm done to the patients.This report addresses the first patient and leaking 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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a cracked y-site was inconclusive due to the nature of the returned sample evidence.The product returned for evaluation was one photograph which depicted a 19ga x 0.75¿ powerloc safety infusion set with y-site.The depicted device was located partially within its folding cardstock.The device appeared free of obvious use residues.The safety was not engaged and end caps were attached to both luer adapters.No obvious damage or defects were observed.No deficiencies were discovered during evaluation of the submitted photograph; however, the depicted device could not be thoroughly examined or functionally evaluated.Consequently this complaint is inconclusive at this time.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer "the iv team received calls from the nursing floors that the y site on this device was cracked and is leaking while in the patient.The iv team so far has had to swap out 3 devices where the y site of the device was cracked." the needle would crack and break when accessing the port of the patient.Additional information on 1/23/23: it was reported there was no immediate harm done to the patients.This report addresses the first patient and leaking device.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G 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 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16277727
• Report Number: 3006260740-2023-00297
• Device Sequence Number: 12527118
• Product Code: FPA
• UDI-Device Identifier: 00801741047916
• UDI-Public: (01)00801741047916
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 0671934
• Device Lot Number: ASGUFC088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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