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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 6MM 90 BX 450 MO PISTON SYRINGE Back to Search Results
Catalog Number 324908
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Skin Inflammation (2443); No Code Available (3191)
Event Date 09/08/2019
Event Type  Injury  
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.
 
Event Description
It was reported that the consumer used the syringe 1. 0ml 6mm 90 bx 450 mo to inject medication, and had "red skin, itchiness", and "hardness underneath" the skin after the injection that felt about "3 inches or 6 inches". The consumer is reportedly allergic to silicone, in which medically graded silicone was explained to be in the needles. The consumer has contacted their pharmacist about the issue. They have also contacted their doctor, who believes the event to be a "histamine reaction", and plans on using "intersalinally". The consumer has used the needles for allergy medication in the past, but has never had this issue occur before. As a result of the event, the consumer has not taken their medication "for a week". The following information was provided by the initial reporter: consumer reported she has been using this syringes recently and she started to notice red skin, itchiness hard underneath after the injection. Sometime the hard feeling for about 3 inches or 6 inches. She is allergic to silicone. She has had face swollen with the c pak mask. She used to use the needles for allergy medicine long back, this has not occurred in the past. Now she has started using the (bpc-157) for tendon ligament. She will try to do the allergy test soon. She has not taken the medicine for a week. She has not contacted the doctor yet. She is planning on contacting the doctor. She has called her pharmacist in canada. Explained consumer we do use medically graded silicone in our needles. Advised to save the sample if re occurrence. She rotates the injection site. She uses the new needle for her injection. From phone call on 09/16/2019 10:12:31: followed up with a consumer, she contacted the doctor, they thing it could be histamine reaction. They are not sure if where that allergic reaction came from. They are planning on using "intersalinally".
 
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Brand NameSYRINGE 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9104271
MDR Text Key162967569
Report Number1920898-2019-01017
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324908
Device Lot Number8029636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2018
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: 09/23/2019 Patient Sequence Number: 1
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