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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
 
Event Description
It was reported that 1 bd syringe 0.3ml 29ga 1/2in hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle and shield separated from the barrel.
 
Event Description
It was reported that 1 bd syringe 0.3ml 29ga 1/2in hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle and shield separated from the barrel.
 
Manufacturer Narrative
H.6.Investigation: customer returned two images of a 0.3ml syringe with no other visible forms of identification.The needle hub on the syringe has not fully separated from the connector at the distal tip of the barrel, but is still raised well above the intended location and at risk of separation.Due to the batch being unknown, no dhr review can be completed.Capa#1630423 was initiated.
 
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Brand Name
BD SYRINGE 0.3ML 29GA 1/2IN
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12544124
MDR Text Key280962637
Report Number1920898-2021-01022
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number326631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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