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

Model Number	MP9213-C
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the maxplus¿ extension tubing set disconnected and leaked from the bd autoguard iv catheter during patient use.
Additional Manufacturer Narrative
The customer¿s report that the set was disconnected and leaking from the bd autoguard iv catheter was not confirmed.The device was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received set and catheter.Functional testing was performed by filling a lab iv syringe with bleach water and attaching it to the set allowing fluid to flow through the whole set by flush.The set flowed freely and showed no signs of disconnecting or leaking throughout the set.The set was then pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.There were no signs of leaking or disconnecting anywhere on the returned set while the tubing was manipulated at each engagement.The root cause could not be identified.
Event or Problem Description
It was reported that the maxplus¿ extension tubing set disconnected and leaked from the bd autoguard iv catheter during patient use.

• Brand Name: MAXPLUS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8600194
• Report Number: 9616066-2019-01264
• Device Sequence Number: 11336173
• Product Code: FPA
• UDI-Device Identifier: 10885403236976
• UDI-Public: 10885403236976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: MP9213-C
• Device Catalogue Number: MP9213-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 ML BD SYRINGE, NEEDLE, THERAPY DATE UNKNOWN; 10 ML BD SYRINGE, NEEDLE, THERAPY DATE UNKNOWN