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

Model Number	324911
Medical Device Problem Codes	Failure to Deliver (2338); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
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 veo¿ insulin syringes with bd ultra-fine¿ gets stuck in barrel.The following information was provided by the initial reporter: stated, stopper gets stuck in barrel making it hard to draw up insulin because plunger rod gets stuck.
Event or Problem Description
It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ gets stuck in barrel.The following information was provided by the initial reporter: stated, stopper gets stuck in barrel making it hard to draw up insulin because plunger rod gets stuck.
Additional Manufacturer Narrative
H6: investigation summary; customer returned (2) unopened polybags for 31gx6mm 0.5ml bd insulin syringes from lot# 1350910.The customer reported that the stopper separates from the plunger rod when drawing insulin, the needle hub separates, and the plunger rod gets stuck when trying to draw.The samples were examined, and no hub separation was initially observed.After removing the cannula shield from each syringe it was observed that 1 out of the 20 syringes exhibited needle hub separation with a damaged barrel tip.The remaining syringes were tested for flow, and all test syringes were able to draw and expel properly.The plunger rod for all 20 syringes was able to move properly through the respective barrel, and no stopper separation was observed.The alleged stopper separates, difficult to operate, and plunger difficult to move issues could not be confirmed based on the samples returned for investigation.A review of the device history record was completed for batch# 1350910.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Embecta was not able to duplicate or confirm the customer¿s indicated failure (stopper separates, difficult to operate, plunger difficult to move).Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿
• 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 ; 8015296192
• MDR Report Key: 15375990
• Report Number: 1920898-2022-00609
• Device Sequence Number: 17500090
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: 00382903249114
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/17/2022

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: 324911
• Device Catalogue Number: 324911
• Device Lot Number: 1350910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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