MAUDE Adverse Event Report: CAREFUSION SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE; SET, I.V. FLUID TRANSFER

Model Number	MV0520
Medical Device Problem Codes	Fluid/Blood Leak (1250); Dent in Material (2526)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
It was reported that in the pharmacy the clinician was using a texium vialshield.While shaking the diluent with the texium vialshield still attached it was noticed that drops of fluid were leaking from the vial.A coworker took a closer look at the vial and the adaptor and saw that there was a dent in the metal coat around the rubber stopper.This caused the device not to sit properly on the vial, which caused the leak.There was no patient involvement.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of vial leaked could not be confirmed due to the product was not returned for failure investigation.The customer reported that the current lot in stock is lot 9249, but it was not confirmed that this was the lot of the event set.Still, the supplier provided dhr for model mv0520 lot 9249 stating that the set was manufactured on 28 december 2019 with a total of (b)(4)units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
Event or Problem Description
It was reported that in the pharmacy the clinician was using a texium vialshield.While shaking the diluent with the texium vialshield still attached it was noticed that drops of fluid were leaking from the vial.A coworker took a closer look at the vial and the adaptor and saw that there was a dent in the metal coat around the rubber stopper.This caused the device not to sit properly on the vial, which caused the leak.There was no patient involvement.

• Brand Name: SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; ste 208; san diego CA 92121 4386
• MDR Report Key: 10057362
• Report Number: 9616066-2020-01605
• Device Sequence Number: 2848550
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: MV0520
• Device Catalogue Number: MV0520
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1