Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SYRINGE 0.5ML 29GA 1/2IN; 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
 

BD SYRINGE 0.5ML 29GA 1/2IN; PISTON SYRINGE Back to Search Results
Catalog Number 326666
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
 
Event Description
It was reported that 1 bd syringe 0.5ml 29ga 1/2in had foreign matter on the device cannula or in the fluid path.The following information was provided by the initial reporter : the customer reported one unused syringe having a blood-like red liquid adhering to the inside of the shield.
 
Event Description
It was reported that 1 bd syringe 0.5ml 29ga 1/2in had foreign matter on the device cannula or in the fluid path.The following information was provided by the initial reporter : the customer reported one unused syringe having a blood-like red liquid adhering to the inside of the shield.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-12.H6: investigation summary: customer returned (1) loose 1/2cc, 12.7mm syringe.Customer states that a blood-like red liquid was adhering to the inside of the shield.The returned syringe was examined and exhibited a reddish material in the shield.The shield was cut to access this material.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood and insulin.This material would not have been acquired during the manufacturing process.Unable to perform dhr check for foreign matter inside shield due to unknown lot number.Bd was able to duplicate or confirm the customer¿s indicated failure for foreign matter on the device cannula or in the fluid path.Root cause is user related as blood and insulin would not have been acquired during the manufacturing process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SYRINGE 0.5ML 29GA 1/2IN
Type of Device
PISTON SYRINGE
MDR Report Key12582725
MDR Text Key274946941
Report Number1920898-2021-01045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K941657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number326666
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Initial Date Manufacturer Received 09/07/2021
Initial Date FDA Received10/06/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/01/2021
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
Patient Sequence Number1
-
-