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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM Back to Search Results
Catalog Number 326668
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: samples were received and an investigation was performed.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.Investigation conclusion: unable to perform complaint lot history check for barrel bowed due to unknown lot number.Customer returned (1) loose 1/2cc, 8mm syringe.Customer states that the barrel was slightly bowed.The returned syringe was examined and exhibited a bowed barrel.Manufacturing ((b)(4)) will be notified of this issue.Unable to perform dhr check for barrel bowed due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bowed barrel).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 automatic syringe assembly machine, which feeds 0.5ml syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components into a syringe.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Device history record; l2l and logbook evaluation: dhr, l2l dispatches, logbook entries could not be looked at as no lot number was given.Root cause for this defect cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the syringe 0.5ml 30ga 8mm experienced product damage while still considered operable.The following information was provided by the initial reporter: noticing that the barrel was slightly bowed before insulin injection, the patient brought the actual sample to the pharmacy.
 
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Brand Name
SYRINGE 0.5ML 30GA 8MM
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11934343
MDR Text Key257424714
Report Number1920898-2021-00632
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2021
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 Number326668
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/07/2021
Initial Date FDA Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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