MAUDE Adverse Event Report: CAREFUSION 60 IN ULTRA MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME2017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An unexpected return confirmed a male luer break.The set was visually inspected for cracks, misassembly or damages to the components.Visual inspection of the set noted that a male luer collar and tip of the extension set was cracked and broken.Examination under magnification observed no stress marks at the break site of the male luer.No tool marks were observed.Functional testing was deemed unnecessary due to the broken male luer collar.The root cause was identified as related to design of the specific male luer component.Device history record for model me2017 could not be performed due to no lot number being provided by customer.
Event or Problem Description
Although an unexpected tubing set with an unspecified issue was returned by the customer, a photo from the receiving lab appeared to show a broken luer.No further information is available.

• Brand Name: 60 IN ULTRA 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: 10328506
• Report Number: 9616066-2020-02314
• Device Sequence Number: 11324264
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: ME2017
• Device Catalogue Number: ME2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1