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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: no photos or physical samples that display the reported condition were available for investigation. A device history review was performed for the reported lot 2007034, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue. Ten retained samples of lot 2007034 were used to conduct a leakage test. The product was visually inspected, no defects or damage was noted, the stopper was properly assembled onto the plunger rod, and no leak was observed. Based on the available information we are not able to determine a root cause at this time. Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported that the bd plastipak¿ concentric luer lock syringe leaked cytostatic medicine past the plunger. The following information was provided by the initial reporter, translated from (b)(6) to english: "when drawing up cytostatic drugs with the 60ml luer lock syringes, the syringe begins to leak. Cytostatics come out of the syringe next to the plunger (black part). Often only in small quantities, today the liquid ran out so that the pad and the ready-made infusion bag were heavily contaminated with cytostatics. ".
 
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Brand NameBD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11276310
MDR Text Key230757030
Report Number3003152976-2021-00061
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2007034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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