MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE

Model Number 324909

Device Problem Defective Device (2588)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd veo insulin syringes experienced product damage while still considered operable.  the following information was provided by the initial reporter: consumer reported, finding one syringe with a damaged barrel.Stated, "flanges" were broken off prior to injection.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary customer returned (1) loose 0.3ml bd insulin syringe.The consumer reported finding one syringe with a damaged barrel, and stated that the "flanges" were broken off prior to injection.The returned syringe was examined, and it was observed that the plunger rod was broken at the thumb press.No damage to the plunger cap, flange, or barrel was observed.A review of the device history record was completed for batch# 1123291.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint bd was able to confirm the customer¿s indicated failure (plunger rod broken).Root cause: maintenance dispatch (l2l) was reviewed, and 1 dispatch was opened for plunger jams / not feeding down the rail.The plungers are guided down a rail by the plunger head.When a jam occurs, the plungers are removed however it the jam is minor and dissipates on its own, it may have weakened the plunger head prior to assembling the syringe.H3 other text : see h10.

Event Description

It was reported that 2 bd veo insulin syringes experienced product damage while still considered operable.  the following information was provided by the initial reporter: consumer reported, finding one syringe with a damaged barrel.Stated, "flanges" were broken off prior to injection.

• Brand Name: BD VEO INSULIN SYRINGE
• Type of Device: INSULIN 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: 13031146
• MDR Text Key: 282613793
• Report Number: 1920898-2021-01313
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324909
• Device Catalogue Number: 324909
• Device Lot Number: 1123291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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