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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10ML BD POSIFLUSH¿ SP SYRINGE HYPODERMIC SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL 10ML BD POSIFLUSH¿ SP SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 306575
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Results: a sample was not returned for evaluation. A complaint history check revealed no similar incidents for reported lot number 6350842. Conclusion: without a sample, an absolute root cause for this incident could not be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
The tip of the 10ml bd posiflush¿ sp syringe broke off and became stuck in the tubing at the dialysis machine.
 
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Brand Name10ML BD POSIFLUSH¿ SP SYRINGE
Type of DeviceHYPODERMIC SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6751527
MDR Text Key81496287
Report Number1911916-2017-00131
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K161552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number306575
Device Lot Number6350842
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2017 Patient Sequence Number: 1
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