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

Model Number ME2017

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: pri tubing;10 ml bd1 normal saline flush syringe; therapy date unk.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that a 10 ml syringe tip broke off inside the female luer of an extension tubing set.Although requested, further information was not provided.

Event Description

It was reported that a 10 ml syringe tip broke off inside the female luer of an extension tubing set.Although requested, further information was not provided.

Manufacturer Narrative

This was an unexpected return.Visual inspection observed the syringe's broken off tip was lodged within the set's female luer.The set was inspected for kinks, holes/tears in the tubing, or damages to the components.Further visual inspection of the syringe (barrel flange mold number n-97 and cavity 38) observed no other issue.No further issue was observed with the set.The broken off syringe tip was unable to be removed.No testing was able to be performed.The device history record for model me2017 could not be performed due to no lot number being provided for the reported suspect set sample.

Event Description

Although an unexpected tubing set with an unspecified issue was returned by the customer, a photo from the receiving lab appeared to show that a 10 ml syringe tip broke off inside the female luer of an extension tubing set.No further information is available.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9925597
• MDR Text Key: 194056504
• Report Number: 9616066-2020-01264
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ME2017
• Device Catalogue Number: ME2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H.10