MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: mz1000-07, therapy date: (b)(6) 2018.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
The customer reported a tubing leak at an unspecified location.It was reported that the male adapter was changed and the set was tightened.There was no report of patient harm.
Event or Problem Description
The customer reported a tubing leak at an unspecified location.It was reported that the male adapter was changed and the set was tightened.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a tubing leak was confirmed.Visual inspection of the set noted a crack along the female luer component of the set, which was found to be cracked along the top and continuing along the length of its luer.The crack was observed to be opposite the injection gate on the luer component.No tool markings were observed around the damaged area.Functional testing confirmed leaking from the damaged female luer.The cause of the leak was due to an observed crack along the set's female luer.The root cause of the observed damage was as a combination of material degradation during the luer component's supplier process and manufacturing factors (solvent and over-torque).

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8078283
• Report Number: 9616066-2018-02252
• Device Sequence Number: 13893105
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: 8110, 8015, PRI TUBING, SYRINGE, TD (B)(6) 2018