MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 320469

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Failure to Deliver (2338)

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

Event Date 02/06/2023

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 ultra-fine¿ ii insulin syringe would draw in a little insulin and leak it back out due to the damaged/"melted" needle/hub.The following information was provided by the initial reporter: "consumer reported needle would not draw insulin; stated, when attempted to draw, a few drops would go in and leak back out of barrel; stated, the part that hold the needle/hub, looks melted; stated, he's been using product for 36 years and never had any issues".

Manufacturer Narrative

H6: investigation summary: customer returned (1) 1.0 ml 30ga syringe, reporting needle hub damage.The syringe was visually verified using magnification and found broken needle hub.Performed a functional test on the syringe using water and observed leak at the barrel tip.Hence, the alleged issue could be confirmed based on the sample retuned for investigation.A review of the device history record was completed for batch# 2178875.All inspections were performed per the applicable operations qc specifications.Based on the sample received, embecta was able to confirm the reported issue.No root cause can be determined at this time.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe would draw in a little insulin and leak it back out due to the damaged/"melted" needle/hub.The following information was provided by the initial reporter: "consumer reported needle would not draw insulin stated, when attempted to draw, a few drops would go in and leak back out of barrel stated, the part that hold the needle/hub, looks melted stated, he's been using product for 36 years and never had any issues".

• Brand Name: BD ULTRA-FINE¿ II INSULIN SYRINGE
• 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: 16475923
• MDR Text Key: 310597281
• Report Number: 1920898-2023-00083
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320469
• Device Lot Number: 2178875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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