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

MAUDE Adverse Event Report: BD BD INTEGRA SYRINGE WITH RETRACTING BD PRECISIONGLIDE NEEDLE 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 BD INTEGRA SYRINGE WITH RETRACTING BD PRECISIONGLIDE NEEDLE PISTON SYRINGE Back to Search Results
Model Number REF 305270
Device Problems Break (1069); Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 02/10/2018
Event Type  malfunction  
Event Description
Wife, rn, administering husband im testosterone. Toward the end of injecting medication a loud pop was heard. Upon lifting the syringe away from the body there was no needle. Both the wife and the husband thought the needle remained in the husband's buttock - right upper outer quadrant. Husband in no acute distress. Tolerating it all very well. Pcp contacted - xray ordered and done. Visited surgeon to discuss removal of needle. It was during this visit that it was discovered that no needle was visible on x-ray. During the visit when surgeon was looking at the syringe he shook it - at that point the needle came flying out into the barrel of the syringe.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INTEGRA SYRINGE WITH RETRACTING BD PRECISIONGLIDE NEEDLE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD
MDR Report Key7276129
MDR Text Key100462194
Report NumberMW5075301
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 305270
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-