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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION SYRINGE 1 ML, 31 G X 8 MM

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BD MEDICAL - DIABETES CARE BD RELION SYRINGE 1 ML, 31 G X 8 MM Back to Search Results
Catalog Number 328506
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/18/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). It is unknown if a sample is available for evaluation. A supplemental report will be filed upon completion of the investigation.
 
Event Description
It was reported that the suspect device broke off during injection and remained in the site. The consumer went to the emergency department and had an x-ray and ultrasound but the needle was not detected and no further interventions were performed. The consumer was able to remove the broken piece at home with tweezers. The consumer states she rotates injection sites and does not reuse.
 
Manufacturer Narrative
Device evaluation: result - a sample was not received for evaluation. A review of the device history record was completed for the reported lot 6116684. All inspections were performed per the applicable operations qc specifications. This lot was packaged jun2016 to 19jun2016. Conclusion - based on the investigation, bd cannot verify a manufacturing related cause of the defect. An absolute root cause for this incident cannot be determined.
 
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Brand NameBD RELION SYRINGE 1 ML, 31 G X 8 MM
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6074890
MDR Text Key59010171
Report Number1920898-2016-00037
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 Patient
Type of Report Initial,Followup
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328506
Device Lot Number6116684
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/03/2016 Patient Sequence Number: 1
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