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

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.

• Brand Name: SYRINGE 3ML LL W/NDL 25X5/8 RB
• Type of Device: PISTON 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 Key: 12610749
• MDR Text Key: 277185641
• Report Number: 1213809-2021-00703
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903095704
• UDI-Public: 00382903095704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309570
• Device Lot Number: 0059816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1