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

Model Number EXT TUBING

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

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.Concomitant medical product: swab cap, therapy date: (b)(6) 2019.

Event Description

It was reported that during a saline infusion a maxzero connector was difficult to remove from a nexiva single port at 96 hr.Change out.The nurse noticed white residue around female end of maxzero and had to damage the cap to remove due to unspecified concerns regarding the peripheral iv.It was later reported by the user that the tubing was bonded to the maxzero connector and not meant to be disconnected.There was no patient harm reported per customer.

Manufacturer Narrative

The customer complaint of maxzero difficulty to disconnect could not be confirmed due to the product was not returned for failure investigation.A photo of a maxzero that was previously bonded to an extension set with a non-bd green curos alcohol disinfectant cap connected to the luer was provided by the customer.The root cause of this failure was not definitively identified.However; due to customer's feedback that "the extension tubing was bonded to the maxzero connector and not meant to be disconnected", the root cause of the customer's experience is due to misuse.

Event Description

It was reported that during a saline infusion, a maxzero extension connector was difficult to remove from a nexiva single port , at the 96 hour change out.The rn noticed "white residue" around the female end of the maxzero and was required to damage the cap to remove due to unspecified concerns regarding the peripheral iv.It was later reported by the user that the extension tubing was bonded to the maxzero connector and not meant to be disconnected.It was confirmed there was no patient harm as a result of this event.

• 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: 8688826
• MDR Text Key: 147879461
• Report Number: 9616066-2019-01555
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 05/14/2019

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 Model Number: EXT TUBING
• Device Catalogue Number: EXT TUBING
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING, NEXIVA SINGLE PORT, TD: (B)(6) 2019.