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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM Back to Search Results
Catalog Number 328506
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: customer returned (69) 1cc, 8mm, 31g relion syringes (9 in an open poly bag, 60 in sealed poly bags) with the shelf carton from lot # 7065640. Customer states that the syringes would not retract and pull out of the arm. Thirty out of 69 returned syringes were examined (9 from the open poly bag, 21 from the sealed poly bags) and no defects were observed on any of the samples. These samples were also tested (#1-9 from the open poly bag, #10-30 from the sealed poly bags) for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0. 0100¿-0. 0105¿). All samples were also tested and all were able to draw and expel properly without any observed defects. All observations fall within specifications. As per manufacturing, a review of the device history record was completed for batch # 7065640. All inspections and challenges were performed per the applicable operations qc specifications. There were seven (7) notifications that did not pertain to the complaint. Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure. Root cause description: bd was not able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a bd relion® insulin syringe 1 ml, 31 g x 8 mm would not retract after use. No injury or medical intervention.
 
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Brand NameBD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
Type of DeviceINSULIN 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
8015652845
MDR Report Key6919636
MDR Text Key245873775
Report Number1920898-2017-00224
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328506
Device Lot Number7065640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2017
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: 10/06/2017 Patient Sequence Number: 1
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