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

Catalog Number 328466

Device Problem Difficult to Advance (2920)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field."there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7198837, expiration date: n/a, manufacture date: 08/31/2017.Medical device lot #: 7016808, expiration date: n/a, manufacture date: 03/09/2017.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 bd insulin syringe with the bd ultra-fine¿ needle plunger rod was difficult to move before injection.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: no samples or photographs were returned, therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7198837.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications noted that did not pertain to the complaint.A review of the device history record was completed for batch# 7016808.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the defect.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7616108
• MDR Text Key: 111996735
• Report Number: 1920898-2018-00416
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328466
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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
• Patient Outcome(s): Other