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

Model Number 328290

Device Problem Material Separation (1562)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 2 of the bd insulin syringes with bd ultra-fine¿ needles had the needle and hubs separate.Verbatim: consumer reported that the needle hubs separated from 2 syringes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023.H6: investigation summary: the customer returned (2) 0.5ml 8mm syringes, reporting needle hub separates.The syringes were visually inspected and observed cannula hub separated from the barrel tip on (1) syringe and no physical damages or issues on the (2) syringe.Based on the sample returned, embecta was able to confirm the customer-indicated failure.A review of the device history record was completed for batch #2063328.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.Based on the samples received, embecta was able to duplicate or confirm the customer-indicated failure.H3 other text : see h10.

Event Description

It was reported that 2 of the bd insulin syringes with bd ultra-fine¿ needles had the needle and hubs separate.Verbatim: consumer reported that the needle hubs separated from 2 syringes.

• Brand Name: BD INSULIN SYRINGES WITH 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17195568
• MDR Text Key: 318033268
• Report Number: 1920898-2023-00385
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282906
• UDI-Public: (01)00382903282906
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328290
• Device Catalogue Number: 328290
• Device Lot Number: 2063328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• 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