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 MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP
  • 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 MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP Back to Search Results
Catalog Number 326666
Device Problem Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 0.5ml 29ga 1/2in 7bag 420cas jp needle pierced through the shield.This was discovered before use.The following information was provided by the initial reporter: the needle pierced thru the shield.When opening the polybag, a nurse got needle stick injury due to cannula through shield.
 
Manufacturer Narrative
H.6.Investigation summary: customer returned seven (6) 29gx12.7mm, 0.5ml bd insulin syringes from an opened polybag from lot 8239936.Consumer reported when opening the polybag, a nurse got needle stick injury due to cannula through shield.All seven returned syringes were examined and it was observed that one syringe exhibited a cannula through shield.The other six syringes did not exhibit a cannula through shield.A review of the device history record was completed for batch# 8239936.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: bd was able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: after visual inspection of the physical sample , we would confirm that it is bent and hooked cannula and happened after getting cannulated, passed the pim inspection for cannula angularity.It must have happened during the process of shielding.Process: racks loaded with hubs travel down a conveyor towards the cannulator.They approach the cannulator turning horizontally in order to receive cannula.Racks pass under mars magnet straightening the cannula in the hubs.The rack passes under two ultraviolet lamps, which causes the adhesive to cure.Then the racks go to the shielder with the use of linear motion.The rack locater positions the racks while getting shielded.The parts are first inspected with an angularity camera, and if the angle of the cannula is too great or there is nothing on that pin, the part is not shielded.The finished product pick and place head won¿t pick it up in the gripper as it is gripping the shield for pick up.Investigation: did not find any l2l dispatches for repairs/ adjustments.There were no notifications pertaining to the complaint.Root cause: root cause cannot be determined as there were no changes to the process, also did not find any repairs and adjustments.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends." rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that syringe 0.5ml 29ga 1/2in 7bag 420cas jp needle pierced through the shield.This was discovered before use.The following information was provided by the initial reporter: the needle pierced thru the shield.When opening the polybag, a nurse got needle stick injury due to cannula through shield.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key9806805
MDR Text Key193403375
Report Number1920898-2020-00217
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2023
Device Catalogue Number326666
Device Lot Number8239936
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2020
Initial Date Manufacturer Received 02/17/2020
Initial Date FDA Received03/09/2020
Supplement Dates Manufacturer Received02/17/2020
Supplement Dates FDA Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-