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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA Back to Search Results
Catalog Number 328421
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
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 1. 0ml 29ga 1/2in bls 500 china leaked. The following information was provided by the initial reporter: when the patient injected subcutaneously to extract the solution, there was leakage found in the outer package.
 
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Brand NameSYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA
Type of DeviceSYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12599264
MDR Text Key282108993
Report Number1920898-2021-01054
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 09/22/2021
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 Number328421
Device Lot Number0280971
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

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