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

Model Number 10010483

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Report source: post market surveillance for med consumables.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 item failed to alarm or occlude after the breakage occurred, and air entered the tubing.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8689736
• MDR Text Key: 147734587
• Report Number: 9616066-2019-01611
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1