MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MICROBORE SET; SET, EXTENSION, INTRAVASCULAR

Model Number	30853
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: value analysis manager.The received unexpected return was confirmed to have a cracked female luer during visual inspection of microbore extension set model 30853.Inspection observed that the female luer component had a 0.3860 inch long crack along the length of the luer and the crack was opposite the injection gate.The set was visually inspected for holes/tears in the tubing or damages to the components.A crack was observed along the side of the set's female luer.The crack was observed to be approximately 0.3860 inches long, opposite the injection gate, and running parallel to the direction of fluid flow.No tool markings were observed around the observed damaged area.No other damages or other issues were observed.The root cause of the crack was identified to be a result of internal stresses created during the manufacturing process.
Event or Problem Description
The set was received as an unexpected return with no other information provided.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: ALARIS PCA MICROBORE SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9835735
• Report Number: 9616066-2020-00955
• Device Sequence Number: 19384409
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: 06/04/2022
• Device Model Number: 30853
• Device Catalogue Number: 30853
• Device Lot Number: 19065362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1