MAUDE Adverse Event Report: CAREFUSION MAXPLUS® CLEAR NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MP1000-C

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: concomitant becton dickinson # (b)(4); bd posiflush¿ iv flush solution sodium chloride was used.Although requested, device 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 valves on the connectors were sticking down and not sealing after being taken out of an iv or syringe.This occurred several times over a period of three weeks and with 4 different patients who had picc or midlines in place for long term therapy.The customer was replacing connectors every 2 to 3 days due to the stick down malfunction although some malfunctioned immediately.The solutions that were being infused during these events: cefepime, ertapenem, daptomycin, ceftriaxone, sodium chloride.The connectors were replaced with no harm to any patient.

Manufacturer Narrative

The customer¿s report of maxplus connectors sticking down was confirmed as per the picture evidence the customer provided.Although the event sample was not received for investigation, 38 new, unopened samples (mp1000-c, lot 18125585) were received and evaluated.Visual inspection found no anomalies.Functional testing of connecting and disconnecting a lab syringe from the received maxplus multiple times did not replicate any instances stick down or delayed piston return.There were no crush marks or tool marks on the samples.The root cause of valve slow return/stickdown was identified as a valve molding issue (mismatch out of specification).

Event Description

It was reported that the valves on the connectors were sticking down and not sealing after being taken out of an iv or syringe.This occurred several times over a period of three weeks and with 4 different patients who had picc or midlines in place for long term therapy.The customer was replacing connectors every 2 to 3 days due to the stick down malfunction although some malfunctioned immediately.The solutions that were being infused during these events: cefepime, ertepenem, daptomycin, ceftriaxone, sodium chloride.The connectors were replaced with no harm to any patient.

• Brand Name: MAXPLUS® CLEAR NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8635174
• MDR Text Key: 145914198
• Report Number: 9616066-2019-01425
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: 10885403223228
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: MP1000-C
• Device Catalogue Number: MP1000-C
• Device Lot Number: 18125585
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2426-0007, TD: UNK.; 2426-0007, TD: UNK.