MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 19GAL YELLOW; SHARPS COLLECTORS

Catalog Number	305613
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Material no.: 305613, batch no.: 8163918.It was reported that before use of the sharps coll chemo 19gal yellow the sharps container was missing a lid.The following information was provided by the initial reporter: details of complaint missing lids for sharps containers.
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.Medical device manufacturer: franklin lakes.Manufacturing location: (b)(6).
Event or Problem Description
Material no.: 305613; batch no.: 8163918.It was reported that before use of the sharps coll chemo 19gal yellow the sharps container was missing a lid.The following information was provided by the initial reporter: details of complaint missing lids for sharps containers.
Additional Manufacturer Narrative
Investigation summary: the actual product nor photo representation was provided.A review of the device history record (dhr) found no manufacturing issued for this reported lot.Also, a review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, ¿missing lids¿.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the box by the weighing system is required to identify or confirm this issue.The root cause is unknown.The issue could have occurred during distribution.Based on these findings, our investigation is inconclusive.Bd will continue to monitor for any trends.
Event or Problem Description
Material no.: 305613; batch no.: 8163918.It was reported that before use of the sharps coll chemo 19gal yellow the sharps container was missing a lid.The following information was provided by the initial reporter: details of complaint missing lids for sharps containers.

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: SHARPS COLLECTORS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8658495
• Report Number: 3005503186-2019-00101
• Device Sequence Number: 2274643
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019

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: 305613
• Device Lot Number: 8163918
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 05/08/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/04/2019; 06/28/2019
• 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