MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
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.H.3.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 scale markings on the bd insulin syringe with the bd ultra-fine¿ needle barrel were thicker, making it difficult to read them and see the insulin inside.The following information was provided by the initial reporter: "consumer reported font on the barrel of syringe seems bolder / thicker, makes it harder to see if insulin has bubbles in insulin or not.You can't see around the markings.This box only.".
Event or Problem Description
It was reported that the scale markings on the bd insulin syringe with the bd ultra-fine¿ needle barrel were thicker, making it difficult to read them and see the insulin inside.The following information was provided by the initial reporter: "consumer reported font on the barrel of syringe seems bolder / thicker, makes it harder to see if insulin has bubbles in insulin or not.You can't see around the markings.This box only.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-may-2023.H6: investigation summary: one unopen polybag of 0.3 ml ¿ 30 g syringes was returned from the customer.It was reported by customer that " font on the barrel of syringe seems bolder / thicker, makes it harder to see if insulin has bubbles in insulin or not.You can't see around the markings.During the investigation the bag was open, and all the syringes were visual inspected.The syringes were compared with a sample from the complaint lab and no issues were observed.A review of the device history record was completed for batch # 2308876 all inspections were performed per the applicable operations qc specifications.Based on the samples received, embecta was not able to confirm the customer¿s indicated failure.The root cause cannot be determined since the issue was not confirmed.H3 other text : see h10.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• 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: 16891847
• Report Number: 1920898-2023-00282
• Device Sequence Number: 5956009
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 07/27/2023

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: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 2308876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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