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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 6MM

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 6MM Back to Search Results
Catalog Number 324919
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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. Investigation conclusion: a complaint lot history check was performed on lot # 0286306 for foreign matter on syringe (syringes are wet). This is the 1st related complaint for foreign matter on syringe (syringes are wet) on lot # 0286306. A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications. 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 10 syringe 0. 3ml 31g 6mm experienced foreign matter on device cannula/in fluid path. The following information was provided by the initial reporter: material no: 324919, batch no: 0286306. Consumer reported first pack opened from this box syringes are wet - voice message.
 
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Brand NameSYRINGE 0.3ML 31G 6MM
Type of DeviceSYRINGE
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 Key11965727
MDR Text Key255104549
Report Number1920898-2021-00651
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number324919
Device Lot Number0286306
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 Received05/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2020
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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