MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM; PISTON SYRINGE

Model Number 324910

Device Problem Volume Accuracy Problem (1675)

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

Event Date 05/11/2022

Event Type  malfunction  

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 Description

It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle 3/10ml 6mm zero point scale mark is lower than it should be and more insulin was drawn.The following information was provided by the initial reporter: the zero point scale mark is lower than it should be.Therefore, more insulin is drawn.

Event Description

It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle 3/10ml 6mm zero point scale mark is lower than it should be and more insulin was drawn.The following information was provided by the initial reporter: the zero point scale mark is lower than it should be.Therefore, more insulin is drawn.

Manufacturer Narrative

The following fields were updated due to additional information: d.9 device available for eval: yes.D.9 returned to manufacturer on: 20-may-2022.H.6 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 not able to duplicate or confirm the indicated issue.Hence a potential root cause cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Customer returned (3) 0.3ml syringes.The syringes were visually inspected and measured using a gauge.The graduation markings on the side of the syringe barrel appear printed lower than average.However, the measurement gauge shows that the markings at the 5 and 30 unit marks are still within specification.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM
• 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 ; 8015296192
• MDR Report Key: 14634316
• MDR Text Key: 296058121
• Report Number: 1920898-2022-00370
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K212499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 324910
• Device Catalogue Number: 324910
• Device Lot Number: 1242719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• 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