MAUDE Adverse Event Report: CAREFUSION SD EXT SET DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	11088483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that ext set dehp free hub cracked.The following information was provided by the initial reporter: material no: 11088483 batch no: unknown.It was reported that hub cracked on med line.Customer response 16-sep-2020: (b)(6) ((b)(4)): was there any adverse event(s) as a result of the reported defect? none reported.O if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.N/a.
Event or Problem Description
It was reported that ext set dehp free hub cracked.The following information was provided by the initial reporter: material no: 11088483 batch no: unknown.It was reported that hub cracked on med line.Customer response 16-sep-2020: (b)(6) (mm report #(b)(6)): - was there any adverse event(s) as a result of the reported defect? none reported.O if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.N/a.
Additional Manufacturer Narrative
It was reported that hub cracked on med line.Received from the customer was a used extension set model 11088483 lot unknown.The as-received set sample was inspected for kinks, holes/tears in the tubing, or damages to the components.There was a crack along the side of the set's female luer lock p/n 630-01364 component (cavity 21).A piece of the top female luer was broken off.The crack was observed to be approximately opposite the injection gate on the luer component.The location of the injection gate (below the wings/tabs) indicates that this female luer was manufactured after the change order (co # 1109132) that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool markings were observed around the observed damaged area.No other damage or issue was observed.Although damage was observed, functional testing was performed.Fluid from a 10lab syringe was pushed through.The fluid leaked from the crack.No other leak was observed.Equipment used (inspection performed on 5-oct2020): - ram optical instrumentation/eq08204/calibration due date 5-feb-2021.Device history record could not be performed on model 11088483 because the lot # for the suspect set was not provided.The customer's report that the hub crack was confirmed upon visual inspection.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.

• Brand Name: EXT SET DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10604061
• Report Number: 9616066-2020-02811
• Device Sequence Number: 2683079
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: Other
• Device Model Number: 11088483
• Device Catalogue Number: 11088483
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: 20200819.; 20200819.
• Outcome Attributed to Adverse Event: Other