MAUDE Adverse Event Report: BECTON DICKINSON HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	323487
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown:  (b)(6), usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Oem manufacture: the manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed, and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that the home sharps container was unable to fit a pen needle with a cover inside it.The following information was provided by the initial reporter: material no.323487, batch no.Unknown.Verbatim: consumer reported he had difficulty detaching the pen needle in the sharp container.Instructed how to remove the pen needle from the container.He was unable to detach the pen needle.Assisted consumer to help removing the pen needle from the cap.
Event or Problem Description
It was reported that the home sharps container was unable to fit a pen needle with a cover inside it.The following information was provided by the initial reporter: material no.323487 batch no.Unknown verbatim: consumer reported he had difficulty detaching the pen needle in the sharp container.Instructed how to remove the pen needle from the container.He was unable to detach the pen needle.Assisted consumer to help removing the pen needle from the cap.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check due to unknown lot number.

• Brand Name: HOME SHARPS CONTAINER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8617443
• Report Number: 2243072-2019-00941
• Device Sequence Number: 2086619
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other