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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 6MM 90 BX 450 MO PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 6MM 90 BX 450 MO PISTON SYRINGE Back to Search Results
Model Number 324908
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: samples were received and an investigation was performed. This is the 2nd complaint for the reported lot number. A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot. Visual inspection of the picture found two spots of adhesive on the cannula, one near the tip, and the other further down. Process summary: this operation assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip. The racks of cannulated barrels then travel through an oven which uses ir light to facilitate adhesive run down and ultraviolet light to cure the adhesive that bonds the cannula to the barrel tip. The cannulated barrels are then conveyed to a machine that inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive. It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields. There were no quality notification or maintenance dispatches created for this issue during the production of this batch. Root cause cannot be determined.
 
Event Description
It was reported when using the bd syringe 1. 0ml 6mm 90 bx 450 mo, the device experienced foreign matter on the device cannula, within the fluid path. This event occurred twice. The following information was provided by the initial reporter. The customer stated: it was reported that it was hard to get needle to go into insulin vial and into skin. Verbatim: from phone call on 2020-10-16 10:43:01: consumer called due to email request he received from bd rep. Stated he initially had 2 syringes where the needle was hard to push into his injection site. Stated last night (10-15-20) he now had a 3rd syringe that wouldn't puncture his skin at all. Email received¿2020-10-14 14:18:52. I have had 2 so far from this box, i didn't get a pic of the first one but it was about f to the same. I notice it was hard to get to go into insulin bottle.
 
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Brand NameBD SYRINGE 1.0ML 6MM 90 BX 450 MO
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12555057
MDR Text Key274067600
Report Number1920898-2021-01030
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number324908
Device Catalogue Number324908
Device Lot Number9070693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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