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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD POSIFLUSH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY BD POSIFLUSH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 306546
Device Problems Flushing Problem (1252); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2022
Event Type  malfunction  
Event Description
The pedi rns alerted me to some faulty flushes.Some flushes are extremely hard to flush.It¿s almost as if the plunger is getting stuck.The pedi rns were thinking their lines weren¿t working until they discovered the problem was actually the flushes.Manufacturer response for 10ml 0.9% ns flush, bd posi flush (per site reporter) i just received word about this issues.(b)(6) has been facing with lot 1244145.I¿m sorry for this has happened and have submitted a pir on your behalf.I listed yourself as the point of contact via email for updates.If you need anything else from me, please let me know.Pir# is (b)(4).
 
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Brand Name
BD POSIFLUSH
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr
franklin lakes NJ 07417
MDR Report Key14694551
MDR Text Key294025996
Report Number14694551
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/13/2022
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
Device Operator Health Professional
Device Model Number306546
Device Catalogue Number306546
Device Lot Number1244145
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/13/2022
Event Location Hospital
Date Report to Manufacturer06/15/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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