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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 7BAG 420CAS JP PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
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. Device manufacture date: unknown. Investigation summary: samples were received and an investigation was performed. Bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. A device history record could not be completed as no lot number was received. 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 syringe 0. 3ml 29ga 1/2in 7bag 420cas jp had its needle separate from the barrel. The following information was provided by the initial reporter, translated from (b)(6): "the customer (animal clinic) reported about needle/shield separation from the barrel. ".
 
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Brand NameSYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
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 Key12298871
MDR Text Key267433360
Report Number1920898-2021-00879
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/21/2021
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 Other
Device Catalogue Number326631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
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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