MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE 3/10ML 29G X 8MM; PISTON SYRINGE

Model Number	328512
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the relion insulin syringe 3/10ml 29g x 8mm stopper was deformed.The following information was provided by the initial reporter: received a voicemail from consumer stating, the "stopper is slanted" making it difficult to use syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 30-jun-2023.Investigation summary: customer returned (16) 0.3ml 31ga 8mm syringes in 4 open polybag from the lot# 2290537.It was reported by the consumer that the "stopper is slanted" making it difficult to use syringe.Stated, it is hard to push the plunger rod because the stopper is slanted inside barrel.The returned syringes were visually examined and observed 9 syringes with slanted stopper (deformed on the top edge of the stopper) that¿s making difficulty in moving the plunger rod.A review of the device history record was completed for batch # 2290537 all inspections were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure.There were no quality notifications or dispatches that pertained to the complaint; therefore, no root cause can be determined.
Event or Problem Description
It was reported that the relion insulin syringe 3/10ml 29g x 8mm stopper was deformed.The following information was provided by the initial reporter: received a voicemail from consumer stating, the "stopper is slanted" making it difficult to use syringe.

• Brand Name: RELION INSULIN SYRINGE 3/10ML 29G X 8MM
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17167860
• Report Number: 1920898-2023-00373
• Device Sequence Number: 5771615
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: (01)00681131311786
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 2290537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Patient Sex: Unknown