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: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE
  • 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 BD NEEDLE SFTYGLD 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 305916
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2019
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 has been reported that one bd¿ needle sftygld 25x1 rb has been found with the needle pulling out of the hub during use.The following has been provided by the initial reporter: it was reported that the needle detached from the hub during use.Verbatim: safety glide 1 inch needle was added to a slip tip boostrix polio syringe and needle prepped without incident.Vaccine injected into deltoid muscle of patient successfully.When nurse removed syringe from arm, the needle had detached from the hub and remained in the child's arm.Enough of the metal remained outside of the child's arm that the nurse was able to use her fingers to remove the needle and discard of it in a biohazard sharps bin.The child was unaware and not affected negatively by the incident.
 
Event Description
It has been reported that one bd¿ needle sftygld 25x1 rb has been found with the needle pulling out of the hub during use.The following has been provided by the initial reporter: it was reported that the needle detached from the hub during use.Verbatim: safety glide 1 inch needle was added to a slip tip boostrix polio syringe and needle prepped without incident.Vaccine injected into deltoid muscle of patient successfully.When nurse removed syringe from arm, the needle had detached from the hub and remained in the child's arm.Enough of the metal remained outside of the child's arm that the nurse was able to use her fingers to remove the needle and discard of it in a biohazard sharps bin.The child was unaware and not affected negatively by the incident.
 
Manufacturer Narrative
H.6.Investigation: two photos and one safetyglide needle attached to an unknown glass syringe in an opened blister pack from batch 7026982 (p/n 305916) was received and evaluated.It was observed in the photos and physical sample there was no cannula present inside the hub, which was rejectable per product specification.Potential root cause for the needle pulling out of hub defect is associated with the needle manufacturing process.Root cause: safetyglide assembly line.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the epoxy to fix it after that the safety mechanism is assembled, then a plastic shield is assembled.In this case the epoxy was not applied to the needle-plastic hub and not detected in the next processes.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect h3 other text : see h.10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD NEEDLE SFTYGLD 25X1 RB
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9506221
MDR Text Key194790356
Report Number1213809-2019-01294
Device Sequence Number1
Product Code FMI
UDI-Device Identifier30382903059165
UDI-Public30382903059165
Combination Product (y/n)N
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number305916
Device Catalogue Number305916
Device Lot Number7026982
Was Device Available for Evaluation? No
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age5 YR
-
-