MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE; HYPDERMIC SINGLE LUMEN NEEDLE

Catalog Number UNKNOWN

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s2; occurrence: unable to perform complaint lot history check due to an unknown lot number for clog.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform complaint lot history check due to an unknown lot number for clog.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the needle only partially dispensed insulin during injection with an unspecified bd pen needle.The following information was provided by the initial reporter: (2 of 2): consumer reported pen needle partially dispenses the inulin during injection.It has been happening since 2 months.She stated the needles does not dispense the full doze, it locks up.She uses 24 unites of insulin.It stops after the 12 unites of insulin.She does the priming; she uses the new pen needle for her injection.She rotates the injection sites.She visually tests the needle to see if it is straight.Sample discarded.She found these issues with 2 boxes.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Type of Device: HYPDERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8859726
• MDR Text Key: 153887888
• Report Number: 2243072-2019-01593
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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