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

Catalog Number	323487
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(4).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.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.Device manufacture date: unknown.Investigation summary: level a investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: unable to perform complaint lot history check for difficult/unable to operate due to unknown lot number.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for difficult/unable to operate due to unknown lot number.Investigation conclusion: 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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 or Problem Description
It was reported that bd home sharps container is not working.This was discovered during use.The following information was provided by the initial reporter: material no.323487 batch no.Unknown.It was reported that home sharps container is not working.Consumer reported difficult time closing lid and once it was closed, could no reopen the lid.Returned call, consumer stated she bought the small sharp container and she wanted to close it since she did not want to leave it open because of the needles inside it.She took it to the pharmacy to cover the lid, they were not able to do it, and finally closed that lid, they could not open the lid.She has used the different companies larger container where they can close it and open it easily.This happened last week.During the process of opening the lid, she broke her finger nails, did not seek medical attention, no other injuries.Explained consumer lid is to close it once its reaches the line and after she closes the lid it gets permanently locked.Explained about the free bracket, offered to send the sharp container and bracket, consumer refused.Consumer left voicemail reporting home sharps container not working.

• Brand Name: BD 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: 9226935
• Report Number: 2243072-2019-02363
• Device Sequence Number: 16698988
• 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
• Report Date (Section B): 10/08/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/23/2019
• 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