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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD 1ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2019
Event Type  malfunction  
Manufacturer Narrative
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 a bd 1ml syringe luer-lok¿ tip had foreign matter. The following was reported. Material no: 309628, batch no: 5049769. It was reported that a white particle was found in the syringe. Event description per customer's attached email states: "on (b)(6) 2019, the reporter contacted requesting replacement for one eylea vial. She stated that (b)(6) 2019, there was a "piece" of something that looked like a "mushroom" within the syringe. The reporter could not elaborate more as to what had occurred as she stated that it was difficult to explain. Patient received eylea dose from another vial. Complaint intake questions: could you provide a photograph that includes the lot number? yes. Note: a photograph was not received by were non-supplied components used in preparing/administering the dose? no. Was the supplied 19g filter needle used to withdraw the dose? no. Was the shipping container damaged? yes. Was the product carton damaged? no. Was the tamper evident seal present on the carton? yes. Was the tamper evident seal intact when the product carton was received? yes. Which component contains the foreign matter: syringe. Syringe location: on the inside of the syringe, in the solution. When was the foreign matter noticed: not answered. Can you describe the foreign matter in terms of shape/color/size? "white mushroom like". Does the foreign matter appear to be free-floating or fixed to the component? stuck in the hole where the needle is attached. Describe any methods used to clean the vial or components? not answered. Was the vial upright or inverted during the withdrawal? unknown. Was the dose prepared in advance? no. Additional questions: was the product stored properly prior to dose preparation? yes. Is the event a result of improper shipping? no. Is the event a result of a storage issue at the physician's office or patient home? no. Was the product prepared for administration? no. Was the product administered to the patient? no".
 
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Brand NameBD 1ML SYRINGE LUER-LOK¿ TIP
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8471685
MDR Text Key147063394
Report Number1213809-2019-00402
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2020
Device Catalogue Number309628
Device Lot Number5049769
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2015
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: 04/01/2019 Patient Sequence Number: 1
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