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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Model Number 328509
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/23/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
Material no. : 328509. Batch no. : 8281954. It was reported by the consumer that during use of the relion® insulin syringe 4 syringes from different bags broke off into her abdomen resulting in one needle having to be removed by medical staff. The doctor made a small incision and removed the needle. The er did not do x-rays, consumer said she marked the spot where she injected so that they would know where to do the incision. The following information was provided by the initial reporter: consumer stated that 4 syringes from different bags in one box broke off into her abdomen after injection. She does not re-use, said she was able to remove 3 of the needles with a tweezers but had to go to the hospital to have the other one removed. The doctor made a small incision and removed the needle. The er did not do x-rays, consumer said she marked the spot where she injected so that they would know where to do the incision.
 
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Brand NameRELION INSULIN SYRINGE
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 Key9564186
MDR Text Key189459172
Report Number1920898-2019-01533
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,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328509
Device Catalogue Number328509
Device Lot Number8281954
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2018
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: 01/08/2020 Patient Sequence Number: 1
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