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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 10ML HYPODERMIC SYRINGE LUER LOK¿

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 10ML HYPODERMIC SYRINGE LUER LOK¿ Back to Search Results
Catalog Number 305959
Device Problem Leak/Splash (1354)
Patient Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: we received 2 pictures for investigation. On visual inspection of the 2 pictures received, it can be observed leakage past the stopper and it is correctly assembled in both syringes. Ten retained samples of 10ll lot 1702010p are evaluated. On visual inspection of these ten retained samples no damage or molding defect can be observed and the stopper is correctly assembled of them. Dhr of lot 1702010p has been reviewed not finding any annotation or deviation regarding the alleged defect. During manufacturing process leak test is performed to every syringe on the assembly machine; in case it fails the defective sample is rejected automatically to scrap. Leak test is performed with the 10 retained samples of lot 1702010p according to procedure and iso 7886-1 annex d and no leakage happens, meeting iso 7886-1. The syringes are disassembled not observing any damage or molding defect in the barrel or in the plunger rod that could have caused the alleged defect. Investigation conclusion: defect: leakage past the stopper (leakage when withdrawing). This issue is not related to a manufacturing defect. The stopper is correctly assembled in the picture received and no defect has been found in any of 10 retained samples that could cause leakage. A fast plunger withdrawing cause a vacuum to be created in the syringe high enough to cause the air contained between the two ribs of the stopper to be released and these get filled with the liquid. The leakage can be caused by bending the plunger when the syringes were almost filled that caused the separation between the stopper and the internal wall of the barrel. When withdrawn is performed till the maximum capacity of the syringe and the plunger is moved applying high flexion in perpendicular direction to syringe axis instead of parallel direction, leakage could happen between stopper rings even behind the stopper. Equipment used for testing: (b)(4). Rationale: based on an evaluation of severity and frequency it was determined that no capa is required at this time, according to procedure (b)(4).
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported, the bd plastipak¿ 10ml hypodermic syringe luer lok¿ had a leak in the syringe above the stopper. Found before use. No serious injury or medical intervention noted.
 
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Brand NameBD PLASTIPAK¿ 10ML HYPODERMIC SYRINGE LUER LOK¿
Type of DeviceHYPODERMIC 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
8015652845
MDR Report Key6871156
MDR Text Key258713268
Report Number3003152976-2017-00051
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2017
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305959
Device Lot Number1702010P
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2017
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: 09/15/2017 Patient Sequence Number: 0
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