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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA PISTON SYRINGE Back to Search Results
Catalog Number 329461
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Date received by manufacturer: bd was initially made aware of this complaint on 2021-02-08. At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident. Additional information was later received on 2021-04-16 that changed the reportability determination. Based on the additional information received, this complaint is now considered to be an mdr reportable incident. Investigation summary: customer returned a single syringe with 0. 5ml graduation markings with no pouch for identification. A visual inspection of the syringe found that its thumbpress was missing, which may have been damage based on the discoloration and irregular angle at the end of the plunger. Additionally, one side of the flange has been bent and contorted, with some light marking on its side. No other defects found. A review of the device history record was completed for batch# 0069680. All inspections and challenges were performed per the applicable operations qc specifications. There were zero (0) notifications noted that pertained to the complaint. Initial evaluation: examination of the photo indicates that the plunger head was not attached to the plunger. This would make the syringe difficult to operate. In addition, one flange attached to the barrel demonstrates a ¿pinched¿ mark. The damage to the flange is minimal allowing the syringe to be functional. Manufacturing evaluation: a review of the syringe assembly line where the syringe in question was produced was completed. Process summary: 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: the device history (dhr) for batch 0069680 was reviewed. The syringes were packaged from 19jun2020 to 22jun2020. During the manufacturing process, the following inspections are completed on regular intervals for the plunger: visual inspection every hour: missing components including plunger rod visual inspection every hour: damage defective components including if a defect is found during an inspection a quality notification is initiated. No quality notifications were written for issues relating to the assembled syringe defect. Investigation conclusion: based on the sample received, bd was able to confirm customer¿s indicated failure of the thumbpress missing. 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. Root cause description: dhr, l2l dispatches, logbook entries were looked at, nothing was found pertaining to this defect. Root cause for this defect cannot be determined. Rationale: based on the investigation, no additional investigation and no capa/sa is required at this time.
 
Event Description
It was reported that syringe 0. 5ml 28ga 1/2in bls 500cas ca was damaged and missing the thumb press. The following information was provided by the initial reporter: material no. 329461 batch no. 0069680. It was reported that 1 syringe was missing the thumb press.
 
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Brand NameSYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA
Type of DevicePISTON 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 Key11702057
MDR Text Key251662616
Report Number1920898-2021-00439
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number329461
Device Lot Number0069680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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