MAUDE Adverse Event Report: CAREFUSION MAXPLUS POSITIVE PRESSURE CONNECTOR; SET, ADMINISTRATION, INFUSION

Model Number	MP1000-C
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient age and dob requested but not provided.
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 reported that the maxplus extension set disconnected from the bd autoguard iv catheter during patient use.Customer-provided photo that shows the maxplus connector mp1000-c attached to a non-bd extension set.Although the initial suspect was documented as mp9213-c, the product grid has been revised to mp1000-c (per photo) and mp1000-c remains as a default suspect.The customer complaint of maxplus¿ extension set disconnected from iv site and leaked could not be confirmed due to the product was not returned for failure investigation.The customer-provided photo shows the maxplus connector mp1000-c attached to a non-bd extension set and does not appear to have been involved in the disconnection described by the customer.However, the photo shows that the distal male luer end of the non-bd extension set appears to have disconnected from the bd autoguard iv catheter (in agreement with the customer's report).This issue has been reported to bd1.The root cause was not identified as no product was returned, the customer-provided photo indicates that the disconnection involves the bd1 autoguard iv catheter.
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.The customer later stated that there were no adverse effects caused to the patient from the event.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8582326
• Report Number: 9616066-2019-01170
• Device Sequence Number: 2935246
• 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: K072542
• 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): 04/15/2019

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: MP1000-C
• Device Catalogue Number: MP1000-C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: BD AUTOGUARD, THERAPY DATE UNKNOWN; BD AUTOGUARD, THERAPY DATE UNKNOWN