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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 25X5/8 RB PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 25X5/8 RB PISTON SYRINGE Back to Search Results
Catalog Number 309570
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 3ml ll w/ndl 25x5/8 rb was damaged and leaked. The following information was provided by the initial reporter: it was reported that " the syringe was leaking and made a mess. Verbatim: customer(consumer) called to file compliant about needle syringe. They went to rn to get shot and when the rn was getting syringe ready the syringe started to leak making a mess, rn stated they no longer felt comfortable giving injection to customer. Customer purchased product from wal mart along with the medication (vit b12 1000unit) the nurse was trying to draw the medication from the bottle and it started leaking out from the plastic at at the bottom where the plunger would sit and it leaked all over. At that point not all the medication that i needed was in the syringe and she did not feel comfortable continuing because of the air bubble. I need that medication 2 times a month. At this time i still have not had my medication. My body does not produce enough vitamin b12 and i am considered severely anemic. I paid 25 dollars for the medication and 4 dollars for the syringe.
 
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Brand NameSYRINGE 3ML LL W/NDL 25X5/8 RB
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12610749
MDR Text Key277185641
Report Number1213809-2021-00703
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309570
Device Lot Number0059816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2020
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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