• 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 1ML 29G 12.7MM 10BAG 500 EU

  • 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 1ML 29G 12.7MM 10BAG 500 EU Back to Search Results
Catalog Number 324827
Device Problem Leak/Splash (1354)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that syringe 1ml 29g 12. 7mm 10bag 500 eu leaked. The following information was provided by the initial reporter: the patient contacted regarding insulin syringes. He injects painkillers with syringes. When he inject, some of the liquid will drain past the syringe. In addition, the injection sometimes makes you sore and the injection site also becomes bloody.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 1ML 29G 12.7MM 10BAG 500 EU
Type of DeviceSYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12601278
MDR Text Key280766538
Report Number1920898-2021-01058
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324827
Device Lot Number9182213
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No

-
-