MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK; SHARPS COLLECTOR

Catalog Number	305425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the lid included with the sharps coll side entry 5.4qt pearl 12/pk was incorrect and wouldn't fit.The defect was discovered before use.The following information was provided by the initial reporter: "customer stated the lids included with the sharps containers are not the correct lids.".
Event or Problem Description
It was reported that the lid included with the sharps coll side entry 5.4qt pearl 12/pk was incorrect and wouldn't fit.The defect was discovered before use.The following information was provided by the initial reporter: "customer stated the lids included with the sharps containers are not the correct lids.".
Additional Manufacturer Narrative
H.6.Investigation: the actual product was returned, and photo representation was provided.A review of the dhr showed there were no issues reported like incorrect lids during the manufacturing process.A review of the nonconformance material reports was performed and the result showed there were no issues reported for the same part number throughout the last twelve months.According to the evidence provided, the issue seems to be related to an incorrect subassembly (box of lids) supplied, which is a manufacturing issue.H3 other text : see h.10.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK
• Common Device Name: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8699924
• Report Number: 2243072-2019-01185
• Device Sequence Number: 13908738
• Product Code: FMI
• UDI-Device Identifier: 50382903054256
• UDI-Public: 50382903054256
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 07/05/2019

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: 305425
• Device Lot Number: 9026910
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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