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

Catalog Number	324909
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd veo¿ insulin syringes with bd ultra-fine¿ needle the plunger is difficult to move.The following information was provided by the initial reporter: pharmacist called on consumers behalf stated, plunger rod is difficult to move, "there is a lot of resistance".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, 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: 04-aug-2023 h6: investigation summary customer returned total of (11) syringe 0.3ml 31ga 6mm, 10 in closed polybag from the lot# 2325824 and one loose.It was reported by the consumer that plunger rod is difficult to move.All the syringes were examined using magnification and found no damages.Functionality test was performed and observed no issues with plunger movement on the return samples.Hence, the reported issue could not be confirmed.A review of the device history record was completed for batch# 2325824.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to confirm the customer indicated failure.Root cause is not determined as the issue is unconfirmed.H3 other text : see h10.
Event or Problem Description
It was reported that during use with bd veo¿ insulin syringes with bd ultra-fine¿ needle the plunger is difficult to move.The following information was provided by the initial reporter: pharmacist called on consumers behalf stated, plunger rod is difficult to move, "there is a lot of resistance".

• Brand Name: BD VEO¿ 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17430852
• Report Number: 1920898-2023-00489
• Device Sequence Number: 15263107
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: (01)00382903249091
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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 Catalogue Number: 324909
• Device Lot Number: 2325824
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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