MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLL 9GAL HINGE PHARMWASTE; SHARPS DISPOSAL

Catalog Number	305634
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
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, a supplemental report will be filed.
Event or Problem Description
It was reported that lids of bd¿ sharps coll 9gal hinge pharmwaste were missing when products were received.The following information was provided by the initial reporter: ¿lids missing on sharps container.¿.
Additional Manufacturer Narrative
H.6.Investigation: it was reported that lids were missing when received.Sample photo representation was provided for evaluation.No photo of the original packaging could be provided for the manufacturer, and the number of missing lids was not confirmed.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance reported for missing lids for the same part number.This lot was confirmed produced after corrective actions.A weight system that provides a weighted label for each final box before shipment has already been implemented for this product to ensure the correct quantity of pieces per box before shipping.It was not possible to confirm that any failure mode was related to the manufacturing process with the information provided since the scale is validated and did not detect any lack of lid components.
Event or Problem Description
It was reported that lids of bd¿ sharps coll 9gal hinge pharmwaste were missing when products were received.The following information was provided by the initial reporter: ¿ lids missing on sharps container.¿.

• Brand Name: BD¿ SHARPS COLL 9GAL HINGE PHARMWASTE
• Common Device Name: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8475669
• Report Number: 2243072-2019-00639
• Device Sequence Number: 11147465
• Product Code: FMI
• UDI-Device Identifier: 50382903056342
• UDI-Public: 50382903056342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 04/29/2019

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: 305634
• Device Lot Number: 8347927
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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