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

Catalog Number	323487
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no.323487.Batch no.Unknown.It was reported that before use of the bd¿ home sharps container the lid was hard to get off.The following information was provided by the initial reporter: lid was hard to get off and she thinks she may have closed it in error before she used it.
Event or Problem Description
Material no.323487.Batch no.Unknown.It was reported that before use of the bd¿ home sharps container the lid was hard to get off.The following information was provided by the initial reporter: lid was hard to get off and she thinks she may have closed it in error before she used it.
Additional 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.Unable to perform dhr check for difficult/unable to operate (lid closed by customer) due to unknown lot number.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.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.

• Brand Name: BD¿ HOME SHARPS CONTAINER
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9136686
• Report Number: 2243072-2019-02159
• Device Sequence Number: 13550087
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/02/2019

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: 04/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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