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

Model Number 324912

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported that a chunk of the bd veo¿ insulin syringe with the bd ultra-fine¿ needle plunger was missing during use.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no".

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 Description

It was reported that a chunk of the bd veo¿ insulin syringe with the bd ultra-fine¿ needle plunger was missing during use.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023.H6: investigation summary: the customer returned (1) 1.0ml g 31 ga 6mm syringe, reporting broken barrel.The syringe was visually examined under microscope and observed no damages to the barrel.A functionality test was performed on the returned sample and no issues related to drawing was observed.Based on the sample received and visual examination, embecta was not able to confirm the reported failure.A review of the device history record was completed for batch# 2227496.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to duplicate or confirm the customer-indicated failure.The root cause cannot be determined, as the reported failure could not be confirmed.

• Brand Name: BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: 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: 16771542
• MDR Text Key: 313613821
• Report Number: 1920898-2023-00239
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 2227496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1