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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE

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BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE Back to Search Results
Catalog Number 328506
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: it was previously reported to refer to capa 91661 for complete investigation results and action plans. However, capa (b)(4) is not applicable to this product issue.
 
Manufacturer Narrative
Investigation summary: one (1) 1cc, 8mm, 31g relion syringe was returned in an open poly bag from lot # 7177611. Customer states that the needle separated from the hub when trying to draw insulin. The returned syringe was examined and exhibited a detached cannula. The loose cannula was returned inside the shield. The sample was examined under the microscope and exhibited adhesive runoff onto the hub and little adhesive inside the hub. The loose cannula was also examined and exhibited adhesive on the cannula shaft. Based on the samples / photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff onto hub). Investigation conclusion: probable root cause determined to be misalignment during application of adhesive on the needle lines. When this occurs, adhesive runover onto the hub or possible the cannula may occur. Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use. Capa (b)(4) was initiated by the (b)(4) plant to address adhesive runover. Capa (b)(4) was initiated by the (b)(4) plant to address 1ml complaints.
 
Manufacturer Narrative
Medical device expiration date: n/a. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that when using a relion® insulin syringe, the needle separated from the hub and remained in the vial. There was no report of injury or medical interventions.
 
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Brand NameRELION® INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7152284
MDR Text Key269223232
Report Number1920898-2017-00409
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328506
Device Lot Number7177611
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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