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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 Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
(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 0.3ml 29ga 1/2in had sterility issues.The following information was provided by the initial reporter : the customer reported that the shield was already detached before use.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-03.H6: investigation summary: customer returned (1) loose 3/10cc, 12.7mm syringe.Customer states that the shield was already detached before use.The returned syringe was examined and exhibited a broken thumbpress on the plunger rod.A review of the device history record was completed for batch# 0167556.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (broken thumbpress).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.H3 other text : see h10.
 
Event Description
It was reported that 1 bd syringe 0.3ml 29ga 1/2in had sterility issues.The following information was provided by the initial reporter : the customer reported that the shield was already detached before use.
 
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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 Key12329104
MDR Text Key266871606
Report Number1920898-2021-00895
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,distributor,foreign
Type of Report Initial,Followup
Report Date 08/18/2021
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 Number326631
Device Lot Number0167556
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Initial Date Manufacturer Received 07/19/2021
Initial Date FDA Received08/16/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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