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

Catalog Number 328838

Device Problem Material Separation (1562)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

It was reported that the bd ultra-fine¿ ii short-needle insulin syringe hub separated from the barrel.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: "it was reported by the customer that the syringes are damaged when unpacking.There were syringes with different types of damages.Such as needle hub fall off from the barrel".

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

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jun-2023.H6: investigation summary: the customer returned (b)(4) 0.5ml 29ga syringes, reporting hub separates, missing plunger, plunger separates, broken barrel, broken needle, broken thumb press, and broken flange.The syringes were visually examined and observed (21) syringes with separated hubs, (2) missing plunger rods, (1) missing stopper, (2) broken barrels, (3) broken thumb press, (1) broken flange, and (1) broken cannula.Based on the samples received and visual examination, embecta was able to confirm the reported failure of hub separates.A review of the device history record was completed for batch # 2059447 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, embecta was able to duplicate or confirm the customer-indicated failure of hub separates.

Event Description

It was reported that the bd ultra-fine¿ ii short-needle insulin syringe hub separated from the barrel.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: "it was reported by the customer that the syringes are damaged when unpacking.There were syringes with different types of damages.Such as needle hub fall off from the barrel".

• Brand Name: BD ULTRA-FINE¿ II SHORT-NEEDLE 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: 16695285
• MDR Text Key: 312865986
• Report Number: 1920898-2023-00204
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care 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: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328838
• Device Lot Number: 2059447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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