MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES 3/10ML 31 GAUGE; PISTON SYRINGE

Model Number	328512
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using relion insulin syringes 3/10ml 31 gauge foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: the syringe have a liquid coming out the needle.The liquid is almost oil feeling, its thicker consistency and does not have an order.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-mar-2023.H6: investigation summary: customer returned (4) 0.3ml 31g 8mm syringes in an open polybag from the lot# 2269224 and (3) printed photos showing fluid at the tip of the cannula.It was reported that the syringe have a liquid coming out the needle.All the return samples were tested and small clear droplet of material came out of the cannula from only one syringe.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.A review of the device history record was completed for batch# 2269224.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the foreign material as silicone.
Event or Problem Description
It was reported while using relion insulin syringes 3/10ml 31 gauge foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: the syringe have a liquid coming out the needle.The liquid is almost oil feeling, its thicker consistency and does not have an order.

• Brand Name: RELION INSULIN SYRINGES 3/10ML 31 GAUGE
• 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 ; 8448235433
• MDR Report Key: 16613922
• Report Number: 1920898-2023-00157
• Device Sequence Number: 6067410
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: (01)00681131311786
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 07/13/2023

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 Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 2269224
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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