MAUDE Adverse Event Report: CAREFUSION MAXPLUS MINIBORE PRESSURE RATED EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MP5310-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
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 during a cat scan, when the extension tubing attached to the peripheral iv was flushed and the syringe removed; blood backed up into the tubing and leaked from the needleless valve.The tubing was replaced and the dressing was changed.The customer states there was no patient harm or medical intervention.
Event or Problem Description
It was reported that during a cat scan, when the extension tubing attached to the peripheral iv was flushed and the syringe removed; blood backed up into the tubing and leaked from the needleless valve.The tubing was replaced and the dressing was changed.The customer states there was no patient harm or medical intervention required as a result of this event.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked from the needleless valve could not be confirmed due to hardened blood in the received set altering the set¿s functionality.Functional testing of flushing fluid through the received set was met with an occlusion due to the hardened blood.The set was visually inspected for misassembly, deformation or damages to the set.Visual inspection found the set has blood throughout the tubing.No other anomalies were observed during visual inspection.The set was submerged in warm water for approximately 10-15 minutes, in an attempt to loosen the hardened blood but was not successful.The root cause of the customer¿s report could not be determined.

• Brand Name: MAXPLUS MINIBORE PRESSURE RATED EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8773158
• Report Number: 9616066-2019-01844
• Device Sequence Number: 16516372
• Product Code: FPA
• UDI-Device Identifier: 10885403236686
• UDI-Public: 10885403236686
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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 Expiration Date: 01/22/2022
• Device Model Number: MP5310-C
• Device Catalogue Number: MP5310-C
• Device Lot Number: 19016615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: PERIPHERAL IV, SYRINGE, TD: (B)(6) 2019
• Patient Age: 65 YR