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

Catalog Number 324911

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/06/2023

Event Type  malfunction  

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 foreign liquid came out of the bd veo¿ insulin syringe with the bd ultra-fine¿ needle when depressing the plunger.The following information was provided by the initial reporter: "i have been using the bf ultra fine syringes for 3 years now.The other day when depressing the excess air out i noticed a liquid coming out of the syringe.I have been told it's a lubricant for the syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 19may2023 h6: investigation summary samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.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 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.See h.10.

Event Description

It was reported that foreign liquid came out of the bd veo¿ insulin syringe with the bd ultra-fine¿ needle when depressing the plunger.The following information was provided by the initial reporter: "i have been using the bf ultra fine syringes for 3 years now.The other day when depressing the excess air out i noticed a liquid coming out of the syringe.I have been told it's a lubricant for the syringe.".

• 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: 16828642
• MDR Text Key: 314176171
• Report Number: 1920898-2023-00265
• Device Sequence Number: 1
• Product Code: FMF
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324911
• Device Lot Number: 2192404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• 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