MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ HOME SHARPS CONTAINER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

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.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in manufacturer name, city and state and mfr site and the franklin lakes fda registration number has been used for the manufacture report number.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 part of the unspecified bd¿ home sharps container plastic broke away after 20 uses of pen needles.The following information was provided by the initial reporter: "we recently purchased the home sharps container as a corrective action plan.We have a student who uses an insulin pen and is unable to give or cap his syringe.When utilizing the pen needle portion we have noticed that the plastic has broken away after only about 20 uses and it is no longer functional.I am wondering if this is an issue you've seen with this product or if this is a result of user error.".

Manufacturer Narrative

H6: 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.See h.10.

Event Description

It was reported that part of the unspecified bd¿ home sharps container plastic broke away after 20 uses of pen needles.The following information was provided by the initial reporter: "we recently purchased the home sharps container as a corrective action plan.We have a student who uses an insulin pen and is unable to give or cap his syringe.When utilizing the pen needle portion we have noticed that the plastic has broken away after only about 20 uses and it is no longer functional.I am wondering if this is an issue you've seen with this product or if this is a result of user error.".

• Brand Name: UNSPECIFIED BD¿ HOME SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16348745
• MDR Text Key: 309588883
• Report Number: 2243072-2023-00174
• Device Sequence Number: 1
• Product Code: MMK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1