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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using relion insulin syringe 3/10ml 29g x 8mm the needle hub separated.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when she removed needle shield, needle hub separated.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-jan-2023 h6: investigation summary the customer returned (1) 0.3ml 31ga 8mm syringe reporting needle hub separates issue.The syringe sample was visually inspected and observed no signs of damage on the barrel or the needle hub.Embecta was able to confirm the reported failure of needle hub separates.A review of the device history record was completed for batch # 9210510 all inspections were performed per the applicable operations qc specifications.Embecta was able to confirm the customer¿s indicated failure of needle hub separates.A definitive root cause cannot be determined.H3 other text : see h10.
Event or Problem Description
It was reported while using relion insulin syringe 3/10ml 29g x 8mm the needle hub separated.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported when she removed needle shield, needle hub separated.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16040256
• Report Number: 1920898-2022-00903
• Device Sequence Number: 4896528
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: (01)00681131311786
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/17/2023

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: Other
• Device Expiration Date: 09/11/2024
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 9210510
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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