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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 305959
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported that 3 bd plastipak¿ hypodermic luer-lok¿ syringes had issues with either water or tsb leaking past the plunger while drawing it up.The following information was provided by the initial reporter: "it has been noted by 3 different personnel that when drawing up 10ml of liquid (either h20 or tsb), the syringe has started leaking down the plunger.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 3 bd plastipak¿ hypodermic luer-lok¿ syringes had issues with either water or tsb leaking past the plunger while drawing it up.The following information was provided by the initial reporter: "it has been noted by 3 different personnel that when drawing up 10ml of liquid (either h20 or tsb), the syringe has started leaking down the plunger.".
 
Manufacturer Narrative
No photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2110020, no deviations or non-conformances were identified during the manufacturing process, however, a quality notification was found related to increased inspections that were performed due to the marking machine randomly causing damage to the barrel.Retained samples from the same lot were used for additional evaluation.All product was visually inspected, no damage or molding defects were observed on any of the products.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedure, including leakage testing.The retained samples underwent these same evaluations and no issues were identified, no leakages were observed and all product was verified to meet required specifications.It is possible the leak reported was due to damage in the barrel, without the physical sample to evaluate we cannot verify this to be true for the incident reported.Based on the available information, we cannot identify definitive root cause at this time.H3 other text : see h10.
 
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Brand Name
BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15331185
MDR Text Key305371289
Report Number3003152976-2022-00391
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305959
Device Lot Number2110020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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