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

Model Number	328411
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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 bd insulin syringe with the bd ultra-fine¿ needle plunger rod was difficult to move during the injection.The following information was provided by the initial reporter: "consumer reported, its difficult to pull on the plunger rod when drawing up and taking injection stated, the plunger rod is a little stiff stated, sometimes he will waste insulin pushing hard consumer asked if company manufactured a different syringe that holds 100 units and is easier to manage stated, as he's gotten older over the years, it is more difficult for him to use his hands because they shake".
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 customer returned a total of (5) 1ml 30ga 12.7mm syringes in an open polybag from lot# 2195800.It was reported by the consumer that "it¿s difficult to pull on the plunger rod when drawing up and taking injection.Stated, the plunger rod is a little stiff".All the syringes were visually verified using magnification and found no damages/issues.Performed a functional test on all syringes using water and was able to draw water into the syringe without any issues.All syringes were performed as intended without issues.Therefore, embecta was not able to confirm the customer indicated issue.A review of the device history record was completed for batch# (b)(4).All inspections were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to confirm the reported issue.The root cause could not be determined because the issue could not be confirmed.H3 other text : see h10.
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle plunger rod was difficult to move during the injection.The following information was provided by the initial reporter: "consumer reported, its difficult to pull on the plunger rod when drawing up and taking injection stated, the plunger rod is a little stiff stated, sometimes he will waste insulin pushing hard consumer asked if company manufactured a different syringe that holds 100 units and is easier to manage stated, as he's gotten older over the years, it is more difficult for him to use his hands because they shake".

• 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: 16921599
• Report Number: 1920898-2023-00291
• Device Sequence Number: 17822588
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 2195800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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