MAUDE Adverse Event Report: CAREFUSION MAXGUARD MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME2010
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Although requested, patient demographic details have not been provided.
Event or Problem Description
It was reported that the tubing broke at the luer lock connection to the syringe and dripped on the pump and leaked during administration of tranexamic acid.No patient harm was reported.
Additional Manufacturer Narrative
Update to b5.
Event or Problem Description
The tubing broke at the luer lock connection to the syringe and dripped on the pump and leaked as the user attempted to infuse tranexamic acid.No patient harm occurred, the leak delayed the patient's surgery while new tubing and medication were obtained.The leaking drug was wasted.
Event or Problem Description
The tubing broke at the luer lock connection to the syringe and dripped on the pump and leaked as the user attempted to infuse tranexamic acid.No patient harm occurred, the leak delayed the patient's surgery while new tubing and medication were obtained.The leaking drug was wasted.
Additional Manufacturer Narrative
The customer¿s report that the tubing broke at the luer lock connection was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.During visual inspection, it was noted that the 30ml bd syringe¿s male luer tip was broken off and lodged inside the extension set¿s female luer inlet port.Clear fluid was also observed in the tubing throughout the set.Closer inspection under a lab microscope observed signs of stress marks on the surfaces of the breakage.No tool marks or signs of over torque were observed.Functional testing could not be performed due to the breakage of the syringe¿s male luer tip lodged inside the extension set¿s female luer.The customer¿s experience was identified to be a break at the bd syringe¿s male luer tip.The root cause of the breakage was not identified.
Additional Manufacturer Narrative
This medwatch report reflects the iv administration (extension) set.A medwatch report for the syringe with the broken tip was submitted by bd under manufacturer report number 2243072-2019-01025.The customer¿s report that the tubing broke at the luer lock connection was not confirmed; the investigation confirmed a break at the bd syringe¿s male luer tip.During visual inspection, it was noted that the 30ml bd syringe male luer tip was broken off and lodged inside the tubing's female luer inlet port.Closer inspection under a lab microscope observed signs of stress marks on the surfaces of the breakage.No tool marks or signs of over torque were observed.Functional testing could not be performed due to the breakage of the syringe¿s male luer tip lodged inside the extension set¿s female luer.
Event or Problem Description
The tubing broke at the luer lock connection to the syringe and dripped on the pump and leaked as the user attempted to infuse tranexamic acid.No patient harm occurred, the leak delayed the patient's surgery while new tubing and medication were obtained.The leaking drug was wasted.

• Brand Name: MAXGUARD MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8667272
• Report Number: 9616066-2019-01477
• Device Sequence Number: 13945203
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: 10885403236235
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2019

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: 12/19/2023
• Device Model Number: ME2010
• Device Catalogue Number: ME2010
• Device Lot Number: 18126031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/08/2019; 08/27/2019; 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 30ML BD SYRINGE EMPTY TRANEXAMIC ACID; 30ML BD SYRINGE EMPTY TRANEXAMIC ACID