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
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.
Event or Problem Description
It was reported that tubing was cracked.Although requested, no additional event and/or patient information was provided.
Additional Manufacturer Narrative
Additional information added; section; b.5.(patient information clarified/detailed).The customer¿s report that tubing was cracked was confirmed due to a crack in the female luer.Visual inspection observed a lateral crack in the female luer wall located at the top end of the female luer opposite of the luer gate.No signs of over torque or other issues were observed.The female luer crack was investigated and it was determined to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the materials used during molding.The pca set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed and the set leaked from the cracked female luer.No other leaks were observed throughout the set.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.
Event or Problem Description
It was reported that tubing was cracked.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: 9851335
• Report Number: 9616066-2020-00817
• Device Sequence Number: 16797320
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/20/2020

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: 30853
• Device Catalogue Number: 30853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1