MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 22G 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	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product cracked while being placed on patient.Additional information received 03/02/2024: it was reported, "employee clamped the port-a-cath needle, cleaned the y site luer lock and then flushed the port-a-cath.Employee then conducted push pull method to remove waste and then obtained blood sample.Employee then cleaned the y site and attempted to flush the y site luer lock which employee discovered was leaking from the y site and luer lock.Employee attempted to replace the luer lock with another item with the same issue.Upon further investigation employee noticed that the y site thread was cracked.Employee informed patient that the port-a-cath needle would need to be removed and a new port-a-cath needle would need to be inserted." it was reported this occurred with two devices.This report addresses the first 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.The manufacturer has received the sample and will evaluate.Results are expected soon.
Additional Manufacturer Narrative
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 as-sca-23-0001.The returned product was a 20g x 3/4" w/y-site miniloc 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 that the product cracked while being placed on patient.Additional information received 03/02/2024: it was reported, "employee clamped the port-a-cath needle, cleaned the y site luer lock and then flushed the port-a-cath.Employee then conducted push pull method to remove waste and then obtained blood sample.Employee then cleaned the y site and attempted to flush the y site luer lock which employee discovered was leaking from the y site and luer lock.Employee attempted to replace the luer lock with another item with the same issue.Upon further investigation employee noticed that the y site thread was cracked.Employee informed patient that the port-a-cath needle would need to be removed and a new port-a-cath needle would need to be inserted." it was reported this occurred with two devices.This report addresses the first device.

• Brand Name: MINILOC SAFETY INFUSION SET 22G 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18963166
• Report Number: 3006260740-2024-01240
• Device Sequence Number: 15445235
• Product Code: FPA
• UDI-Device Identifier: 00801741048081
• UDI-Public: (01)00801741048081
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• 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): 06/17/2024

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: 01/14/2026
• Device Model Number: N/A
• Device Catalogue Number: 0682234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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