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

Catalog Number	305490
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
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.Medical device expiration date: n/a.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.
Event or Problem Description
Material no.: 305490 batch no.: 8338003.It was reported that before use of the sharps coll 8.2qt red vented cap the lid of the sharps container was discovered broken in box.The following information was provided by the initial reporter: lid of sharps container broken when package was opened.No damage to outside of box or other products inside box.
Event or Problem Description
Material no.: 305490.Batch no.: 8338003.It was reported that before use of the sharps coll 8.2qt red vented cap the lid of the sharps container was discovered broken in box.The following information was provided by the initial reporter: lid of sharps container broken when package was opened.No damage to outside of box or other products inside box.
Additional Manufacturer Narrative
H.6.Investigation summary: an investigation could not be completed as not enough information is available.Pictures shows damage to the cap however picture also shows bottle was in a single pack box not the original 12pcs box that pps would have used (pps packs this product 12 per box never single packs).No ncr's were raised during the production of this lot.All testing was within specification.The manufacturer believes that if the product was repackaged and shipped the damage most likely occurred then.The root cause is related to a distributor; repacking and distribution, or damage during repackaging or shipping.No capa is required at this time.The supplier has notified operators to look for any deformities with caps.H3 other text : see section h.10.

• 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: 9129650
• Report Number: 2243072-2019-02138
• Device Sequence Number: 2352189
• Product Code: MMK
• UDI-Device Identifier: 50382903054904
• UDI-Public: 50382903054904
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 8338003
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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