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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SWITZERLAND SARL BD MAXPLUS EXTENSION SET (MINIBORE) WITH CLEAR NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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BD SWITZERLAND SARL BD MAXPLUS EXTENSION SET (MINIBORE) WITH CLEAR NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 20036437
Device Problems Break (1069); Separation Failure (2547)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
Patient came for a scheduled picc line dressing change. There are two ports (red and purple) who each had an extension set (minibore) with clear needleless connector n the picc line. The nurse tried to remove/disconnect the extension set from the purple port, but it would not disconnect. The nurse tried using a kelly clamp tool to assist in disconnecting the extension set from the port but instead the inside of the cap from the extension set connector broke off. The part that broke off got lodged into the port.
 
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Brand NameBD MAXPLUS EXTENSION SET (MINIBORE) WITH CLEAR NEEDLELESS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD SWITZERLAND SARL
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key11574291
MDR Text Key242410551
Report Number11574291
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number20036437
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2021
Event Location Other
Date Report to Manufacturer03/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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