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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 10 BAG 500 WAL PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE Back to Search Results
Model Number 328509
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that syringe 0. 5ml 31ga 8mm 10 bag 500 wal plunger cap was damaged. The following information was provided by the initial reporter: material no: 328509 batch no: unknown it was reported that one syringe had a plunger cap that looked like it had been chewed by a machine. Verbatim: pharmacist called to report issue on behalf of consumer. Stated one relion syringe looks as if the plunger cap was chewed by a machine. One syringe affected. Stated she has reported previous complaints on behalf of this consumer. Advised that only a mail kit would be sent at this time.
 
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Brand NameSYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11291245
MDR Text Key230994294
Report Number1920898-2021-00163
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328509
Device Catalogue Number328509
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
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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