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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 60ML E/T PISTON SYRINGE

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BECTON DICKINSON, S.A. SYRINGE 60ML E/T PISTON SYRINGE Back to Search Results
Model Number 300866
Device Problem Fungus in Device Environment (2316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one photo was provided to our quality team for investigation. Upon visually inspecting the photo, a brown particle was observed between the stopper and plunger. A device history review was performed for the reported lot 2006283, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue. Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter. The assembly machine has a vacuum system to reduce any foreign particles within the syringe. 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 procedures. Without the actual sample to evaluate, we cannot verify the composition or origin of the particle, therefore a definitive root cause cannot be determined at this time.
 
Event Description
It was reported that a syringe 60ml e/t had mold presence before use. The following was reported by the initial reporter: "contaminant that looks like piece of fluff or mould found in sterile syringe. Noticed by operator and discarded before use. No harm caused. ".
 
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Brand NameSYRINGE 60ML E/T
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11925075
MDR Text Key263419146
Report Number3003152976-2021-00309
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number300866
Device Catalogue Number300866
Device Lot Number2006283
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 Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2020
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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