MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE INSULIN SYRINGE NEEDLE

Catalog Number 324826

Device Problems Volume Accuracy Problem (1675); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

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 scale marking error occurred with a bd micro-fine¿ insulin syringe needle.The following information was provided by the initial reporter, "scale not correctly printed and the syringe plunger at an angle.".

Event Description

It was reported that scale marking error occurred with a bd micro-fine¿ insulin syringe needle.The following information was provided by the initial reporter, "scale not correctly printed and the syringe plunger at an angle.".

Manufacturer Narrative

Investigation: customer returned (6) 3/10cc, 8mm, 30g syringes in an open poly bag from lot # 8022736.Customer states that the scale is not correctly printed and the syringe plunger is at an angle.All returned were examined and no defects were observed on the plunger rods or the stoppers of any of the returned samples.All samples were also tested using the plug gauge and no defects were observed on the scale of any of the returned samples.A review of the device history record was completed for batch# 8022736.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were two (2) notifications [(b)(4)] noted for missing zero lines.There were three (3) notifications [(b)(4)] noted for missing print.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD MICRO-FINE INSULIN SYRINGE NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8755235
• MDR Text Key: 150603943
• Report Number: 1920898-2019-00608
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382904826017
• UDI-Public: 382904826017
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 324826
• Device Lot Number: 8022736
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other