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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 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 328438
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0006864, medical device expiration date: 2025-01-31, device manufacture date: 2020-01-06, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown. 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 an unspecified number of bd insulin syringe with bd ultra-fine¿ needles experienced the needle going through the shield after recapping and leakage during use. The following information was provided by the initial reporter: material no. 328438 batch no. 0006864, unknown. Complaint 1 of 2. Consumer reported when removed the needle shields finding the needles to be bent. Replaces the shield to the syringe the needle goes thru shield and sticks his thumb. Advised consumer not to reshield. No medical attention received or will be received for this incident. Consumer reported removes needle shield does not look at the needle completes the injection but finds the needle bent and insulin rolling down stomach. Consumer reported reuses the syringe for his night time injection. He injects 4-5 times a day. Lot #: 0006864 plus other boxes unknown lot #s. Catalog#: 328438. Date of event: unknown.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
Type of DevicePISTON 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
8015652341
MDR Report Key10479499
MDR Text Key206359754
Report Number1920898-2020-01147
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328438
Device Catalogue Number328438
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated by Manufacturer? Yes
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: 09/01/2020 Patient Sequence Number: 1
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