MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MV0520

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that while the pharmacy technician was unscrewing the syringe from the medication vial, the syringe broke off and stayed in the vial.

Manufacturer Narrative

The customer¿s report of breakage was confirmed.However, the breakage occurred on the smartsite component of the vial adapter and not on the syringe.The syringe and vad were visually inspected for obvious damage such as incomplete bonding engagements, cracks/fractures, crazing, breaks or other damage and anomalies.Visual inspection of the set noted the white female luer adapter (fla), of the vad¿s smartsite component that is welded to the clear smartsite body was broken off from the body of the smartsite.Further inspection of the fla end found a remnant ring of the clear smartsite body remaining within (still welded to) the fla.The corresponding surface areas of the breakage were white with uneven and jagged edges (not a ¿clean¿ break).The uneven breakage and white areas are an indication of stress from the application of external force.Examination of the fla under magnification revealed that the threads of the smartsite were turned upwards indicating possible over-tightening to the texium mating component.No other anomalies or evidence of damage were observed.Functional testing was not performed due to the obvious damage.The breakage was caused by an external force.The root cause of the external force was not identified.

Event Description

It was reported that while the pharmacy technician was unscrewing the syringe from the 20mm medication vial access device, the syringe broke off.There was no patient involvement.

• Brand Name: SMARTSITE VIALSHIELD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9089781
• MDR Text Key: 159356533
• Report Number: 9616066-2019-02641
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10885403221699
• UDI-Public: 10885403221699
• Combination Product (y/n): N
• PMA/PMN Number: K132863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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
• Device Operator: Health Professional
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) MV0520, THERAPY DATE, UNKNOWN; MV0520