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

Model Number	328519
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the relion® insulin syringe needle broke off into the consumer's stomach during the injection.The consumer visited the doctor, but the x-ray was not completed, and it was advised to wait for the needle to eventually come out on its own.The following information was provided by the initial reporter: "consumer reported found a few syringes that broke during injection.One syringe broke off in stomach informed his doctor.Doctor view site did not complete xray just advised to wait for needle to come out on its own.It did come out on own.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
Event or Problem Description
It was reported that the relion® insulin syringe needle broke off into the consumer's stomach during the injection.The consumer visited the doctor, but the x-ray was not completed, and it was advised to wait for the needle to eventually come out on its own.The following information was provided by the initial reporter: "consumer reported found a few syringes that broke during injection.One syringe broke off in stomach informed his doctor.Doctor view site did not complete xray just advised to wait for needle to come out on its own.It did come out on own.".

• Brand Name: RELION® INSULIN SYRINGE
• Common Device Name: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13952100
• Report Number: 1920898-2022-00197
• Device Sequence Number: 6626742
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown