• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL PISTON SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The medical device lot #: 7300855. Medical device expiration date: 2022-10-31. Device manufacture date: 2017-12-05. Medical device lot #: 8176527. Device manufacture date: 2018-07-02. 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 1ml ll had foreign matter. This occurred on 20 occasions. The following information was provided by the initial reporter: we have been notified by baxter regarding an issue they have observed on the bd syringe that we package, sterilise and supply to them for their compounding operations. They have noticed a cloudy appearance on the surface of the barrel inside the syringe, in the space encapsulated by the rubber plunger. It seems to affect a few different batch numbers to different degrees. Although described as a "cloudy" appearance, some of the samples i've managed to look at more closely appear to have crystallised deposits on the inner surface of the barrel. These are unopened, in their original blister packs, and apart from being subjected to an eo sterilisation cycle and subsequent storage, there's nothing remarkable about these.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 1ML LL
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 Key12616576
MDR Text Key276238996
Report Number1213809-2021-00706
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K941562
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 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309628
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-