MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 8.2QT RED VENTED CAP; SHARPS COLLECTOR

Catalog Number	305490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
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.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.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 (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 sharps coll 8.2qt red vented cap experienced a permanent lid lock, and difficult assembly -lid does not fit collector.Product defects were noted prior to use.The following information was provided by the initial reporter: material no: 305490.Batch no: unknown.Per customer email: i need directions on how to properly dispose of one of your sharps containers that has a manufacturing error.The lid on this container was cut off too short and is missing the plastic part that seals/locks the container.We have not used the container or put any sharps inside.
Additional Manufacturer Narrative
Investigation: at this point an investigation cannot be completed as not enough information is available.No pictures of damaged/broken tab.No lot number is available to investigate caps received.Dhr could not be reviewed.
Event or Problem Description
It was reported that the sharps coll 8.2qt red vented cap experienced a permanent lid lock, and difficult assembly -lid does not fit collector.Product defects were noted prior to use.The following information was provided by the initial reporter: material no: 305490, batch no: unknown.Per customer email: i need directions on how to properly dispose of one of your sharps containers that has a manufacturing error.The lid on this container was cut off too short and is missing the plastic part that seals/locks the container.We have not used the container or put any sharps inside.

• Brand Name: SHARPS COLL 8.2QT RED VENTED CAP
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9175223
• Report Number: 2243072-2019-02265
• Device Sequence Number: 2237766
• Product Code: MMK
• UDI-Device Identifier: 50382903054904
• UDI-Public: 50382903054904
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: Other
• Device Catalogue Number: 305490
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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