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

Catalog Number 324916

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/22/2018

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 needle separated on a bd ultra-fine¿ insulin syringe after inserting it into the insulin bottle.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one loose 3/10cc syringe.The returned syringe was examined and exhibited a detached cannula.The loose cannula was returned in the shield.The sample was examined under the microscope and exhibited little adhesive in the hub.The loose cannula was also examined and exhibited adhesive on the cannula shaft.A review of the device history record was completed for batch# 7030961.All inspections and challenges were performed per the applicable operations qc specifications.There were three notifications noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (detached cannula).Probable root cause is likely to be a misalignment of the adhesive nozzle during cannulation on the needle lines.When this occurs, adhesive may be either over-dispensed or mis-dispensed, missing the hub assembly entirely.This would lead to cannula separates and easier cannula pull outs by the consumer.Prior work with capa (b)(4)to address shield difficult to remove/adhesive run-over and its associated root cause(s) identified the primary root cause for misplacement of adhesive on the needle lines.Batch# 7030961 was manufactured prior to implementation of corrective/preventive actions associated with this capa.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7431207
• MDR Text Key: 105697232
• Report Number: 1920898-2018-00207
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 324916
• Device Lot Number: 7030961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR