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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE Back to Search Results
Model Number 328512
Device Problems Failure to Deliver (2338); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 3 syringe 0. 3ml 31ga 8mm 10bag 500 wal were damaged and unable to aspirate during use. The following was reported by the initial reporter: "it was reported that the consumer had difficulty drawing up the medication with three syringes. Also, the plunger bent and was very weak/thin. Verbatim: relion consumer reported difficulty drawing up his medication with 3 syringes. Stated the plunger also seems to bend and is very weak and thin on these syringes. Stated this product is a mess and he will not be using them anymore. Request refund. Lot #0160001cat # 328512 date of event: (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021 for all issues reported samples: yes, sending mail kit".
 
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Brand NameSYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL
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
8015296192
MDR Report Key11240770
MDR Text Key242274899
Report Number1920898-2021-00119
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
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328512
Device Catalogue Number328512
Device Lot Number0160001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
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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