• 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 10ML SYRINGE LUER-LOK¿ TIP HYPODERMIC 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 10ML SYRINGE LUER-LOK¿ TIP HYPODERMIC NEEDLE Back to Search Results
Catalog Number 301029
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem Eye Injury (1845)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
Catalog number and lot number updated.
 
Manufacturer Narrative
Results: one sample was returned and evaluated. The syringe was found to have a crack in the barrel wall starting near the 7ml grad line to the 1ml grad line. The crack ran through the printed scale specifically the graduated numbers. The origination of the crack is a slight impact point near the 7ml scale marking. This impact is considered slight due to the minimal surface damage observed. The syringe has multiple liquid droplets observed in the eh syringe fluid path. Blood was not observed in the sample as described in the detail by the end user. The printed scale is full and complete with no print defects. The plunger rod did not have any visible damage. During the printing process the syringe barrel is contacted by a print pad. This contact requires even pressure between the syringe barrel and print pad. If the barrel is cracked the printed image will not transfer properly causing visual defects in the printed image on the syringe barrel. As stated earlier the print does not have any visual defects therefor we can conclude the barrel was not cracked prior to the printing process. During assembly process the syringe barrel moves through machine dials. These dials have barrel pockets specifically sized for the diameter of the barrel if damage or crack to the barrel was caused in the affected as stated earlier the crack originated from a slight impact near the 7ml scale marking therefor we can conclude the barrel was not cracked in the assembly process. A device history review was done on lot number #6274907 no defects were found. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported there was a crack in a bd 10ml syringe luer-lok¿ tip. When the er resident flushed the picc line, blood mixed with normal saline and sprayed out the side of the syringe into the residents eye. She was immediately taken to the eye wash station. Medical interventions are unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD 10ML SYRINGE LUER-LOK¿ TIP
Type of DeviceHYPODERMIC NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6761678
MDR Text Key258953680
Report Number1213809-2017-00046
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Catalogue Number301029
Device Lot Number6274907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2017 Patient Sequence Number: 1
-
-