MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 syringes thumb press was broken.The following information was provided by the initial reporter: it was reported that broken/missing from the plunger rod.Also reported that the orange plunger cap is stuck in the seal of the back.Verbatim: consumer reported that the thumb press is broken/missing from the plunger rod.Also reported that the orange plunger cap is stuck in the seal of the back.The issues involve one syringe.Lot #: 2283727, catalog #: 328520, date of event: unknown, samples: available - sending mail kit.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: (b)(6) 2023 h6: investigation summary samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.
Event or Problem Description
It was reported that the relion insulin syringes thumb press was broken.The following information was provided by the initial reporter: it was reported that broken/missing from the plunger rod.Also reported that the orange plunger cap is stuck in the seal of the back.Verbatim: consumer reported that the thumb press is broken/missing from the plunger rod.Also reported that the orange plunger cap is stuck in the seal of the back.The issues involve one syringe.Lot #: 2283727 catalog #: (b)(4) date of event: unknown samples: available - sending mail kit.

• Brand Name: RELION INSULIN SYRINGES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16907174
• Report Number: 1920898-2023-00287
• Device Sequence Number: 6837280
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: (01)00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 2283727
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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