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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN; PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date : unknown.Initial reporter phone# : (b)(6).Initial reporter zip code : (b)(6).A device evaluation is pending 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 syringe 0.3ml 29ga 1/2in was unable to deliver insulin or medication.The following information was provided by the initial reporter : the customer reported that a polybag was opened and bdj confirmed from returned samples that the needle shield with hub was detached from the barrel.
 
Manufacturer Narrative
H6: investigation summary: the images provided for this complaint shows a single syringe that has had its needle hub separate from the barrel of the syringe.No images were provided showing a polybag with a damaged/open seal.Due to the batch being unknown, no dhr review can be completed.Since no samples and/or photo(s) of the samples were received for investigation, bd was not able to replicate 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.The root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h10.
 
Event Description
It was reported that 1 syringe 0.3ml 29ga 1/2in was unable to deliver insulin or medication.The following information was provided by the initial reporter : the customer reported that a polybag was opened and bdj confirmed from returned samples that the needle shield with hub was detached from the barrel.
 
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Brand Name
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 Key12010448
MDR Text Key257414666
Report Number1920898-2021-00667
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K941657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
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 Received06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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