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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM; PISTON SYRINGE Back to Search Results
Catalog Number 328506
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter city and state : (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 bd syringe 1.0ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : the consumer reported that 1 syringe needle hub was broken off in shield.Occured date : unknown.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 7/27/2021 h.6.Investigation: customer returned a single 1ml syringe with no other identification.The integrated needle hub had partially broken away from the barrel of the syringe at the hub¿s base.The split starts at one side of the base and stretches across the transverse plane, approximately 2/3rds of the distance through the base, resulting in the separated portion sticking out at an angle from the rest of the syringe.This damage may have happened as the result of high stresses placed across the needle hub.There did not appear to be any other damage to the syringe.A review of the device history record was completed for batch# 1011823.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of the syringe¿s needle bending.The root cause of the barrel tip breaking appears to be high stresses placed across the barrel and needle hub.H3 other text : see h.10.
 
Event Description
It was reported that 1 bd syringe 1.0ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : the consumer reported that 1 syringe needle hub was broken off in shield.Occured date : unknown.
 
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Brand Name
SYRINGE 1.0ML 31GA 8MM
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key12277492
MDR Text Key265183418
Report Number1920898-2021-00852
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 consumer,other
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328506
Device Lot Number1011823
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Initial Date Manufacturer Received 07/07/2021
Initial Date FDA Received08/04/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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