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

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

Patient Problem Pain (1994)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

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.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.B.3.Date of event is unknown; awareness date has been used for this field.E.1.Address information was not able to be obtained, therefore, nj was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using unspecified bd pen needle the medication could not be completely delivered.There was no report of patient impact.The following information was provided by the initial reporter: i am having an increased amount of difficulty with 32g x 5/32" needles with my insulin.On an increasing basis, they are jamming and will not inject the correct amount of insulin.They will allow 6 - 10 units out of the 48 i am supposed to take and then they jam solid and will not move.I go through extra needles and the injection is painful due to all the attempts to get a complete dose.

Manufacturer Narrative

H.6 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.

Event Description

It was reported while using unspecified bd pen needle the medication could not be completely delivered.There was no report of patient impact.The following information was provided by the initial reporter: i am having an increased amount of difficulty with 32g x 5/32" needles with my insulin.On an increasing basis, they are jamming and will not inject the correct amount of insulin.They will allow 6 - 10 units out of the 48 i am supposed to take and then they jam solid and will not move.I go through extra needles and the injection is painful due to all the attempts to get a complete dose.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Type of Device: HYPODERMIC 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17853193
• MDR Text Key: 324727870
• Report Number: 2243072-2023-01760
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 09/18/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/04/2023
• 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