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

Model Number 10010483

Device Problem Material Integrity Problem (2978)

Patient Problem 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 the syringe adapter set is snapping off at the tip.

Manufacturer Narrative

No product will be returned.The photo provided by the customer shows the upper fitment was completely separated from the vented spike.The root cause of this failure was not identified.

Event Description

The customer notified bd with a reported issue that the syringe adapter set is snapping off at the tip.

• Brand Name: ALARIS SYRINGE ADAPTER SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8695623
• MDR Text Key: 147902204
• Report Number: 9616066-2019-01567
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (y/n): N
• PMA/PMN Number: K934095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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 Expiration Date: 04/24/2021
• Device Model Number: 10010483
• Device Catalogue Number: 10010483
• Device Lot Number: 18046888
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100,SYRINGE, THERAPY DATE UNK; 8015,8100,SYRINGE, THERAPY DATE UNK