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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 328438
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. Investigation results: summary: investigation summary: customer returned (1) 3/10 cc, 8 mm, 31 g syringe in an open poly bag from lot # 6179832. Customer states that the plunger rod was difficult to move. The returned syringe was tested and the plunger rod was able to be exercised in the barrel without any observed defects. A review of the device history record was completed for batch # 6179832 all inspections were performed per the applicable operations qc specifications. There were five (5) notifications (b)(4) noted that did not pertain to the complaint. Conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: 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. Based on the above, no additional investigation and no capa is required at this time root cause: root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that the plunger rod on a bd insulin syringe with bd ultra-fine¿ needle was difficult to move. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE WITH NEEDLE
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 Key7519170
MDR Text Key108895972
Report Number1920898-2018-00314
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
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328438
Device Lot Number6179832
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2016
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: 05/16/2018 Patient Sequence Number: 1
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