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

Catalog Number	328466
Medical Device Problem Codes	Defective Component (2292); Inaccurate Delivery (2339); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd insulin syringes with bd ultra-fine¿ needle the stopper was misaligned, making the plunger movement difficult and unable to deliver medication.Report 1 of 2.The following was received by the initial reporter: consumer reported, she was able to draw up her insulin but when she tried to take the injection, the "stopper" became stiff and shifted inside the barrel making it difficult to push the plunger rod.Stated, only a small amount of insulin went into the injection site.Stated, the first unit marking on the barrel various between syringes.Stated, she is concerned with drawing up too much or too little insulin due to the inconsistencies with scale markings.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 08-sept-2023 h.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number for the plunger and the stopper and the 2nd complaint for the reported lot number for the syringe.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 not 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.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd insulin syringes with bd ultra-fine¿ needle the stopper was misaligned, making the plunger movement difficult and unable to deliver medication.Report 1of 2.The following was received by the initial reporter: consumer reported, she was able to draw up her insulin but when she tried to take the injection, the "stopper" became stiff and shifted inside the barrell making it difficult to push the plunger rod.Stated, only a small amount of insulin went into the injection site stated, the first unit marking on the barrel various between syringes.Stated, she is concerned with drawing up too much or too little insulin due to the inconsistencies with scale markings.

• Brand Name: BD INSULIN SYRINGES WITH 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17650964
• Report Number: 1920898-2023-00592
• Device Sequence Number: 12340634
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: (01)00382908466035
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 11/02/2023

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 328466
• Device Lot Number: 1221996
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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