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

Catalog Number 320440

Device Problems Detachment Of Device Component (1104); Mechanics Altered (2984)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 by a medical professional that there was difficult plunger movement while using bd insulin syringes with the bd ultra-fine¿ needles; stating the ¿plunger rods are stiff and stopper separates.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Date received by manufacturer correction.The date received by manufacturer field has been updated to reflect the corrected date of 12/20/2017.

Manufacturer Narrative

Investigation results.Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod difficult to move and the 1st related complaint for stopper separates on lot # 7177921.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed.As per manufacturing, a review of the device history record was completed for batch # 7177921 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.The root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7187754
• MDR Text Key: 97670199
• Report Number: 1920898-2017-00435
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 320440
• Device Lot Number: 7177921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other