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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE Back to Search Results
Catalog Number 928857
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2021
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Due to the batch being unknown, no dhr review can be completed. As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that the syringe 0. 5ml 31ga 8mm 10bag 500 pl/wg scale markings were not printed to the top of the barrel. The following information was provided by the initial reporter: "i purchased 6 packages of insulin syringes and the quality control was terrible. Some were missing the plungers, some did not seem to be printed all the way to the top. ".
 
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Brand NameSYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
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 Key12294076
MDR Text Key265592763
Report Number1920898-2021-00874
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 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number928857
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
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

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