MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA 3.0L YELLOW; SHARPS COLLECTOR

Catalog Number 300450

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

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 Description

It was reported that the lid was missing from the sharps coll (b)(6) 3.0l yellow and noticed before use.The following information was provided by the initial reporter: "customer received the product without the lid".

Event Description

It was reported that the lid was missing from the sharps coll canada 3.0l yellow and noticed before use.The following information was provided by the initial reporter: "customer received the product without the lid".

Manufacturer Narrative

Investigation summary: a photo representation and one sample was received.However, no additional evidence of original packaging was available.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported lot was performed for the past 12 months.There were no manufacturing or material defects reported that could have caused or contributed to the reported incident of missing lids.The photo provided may confirm repackaging by the distributor.A weighing system has already been implemented as corrective action for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the original box by the weighing system is required to identify or confirm this type of issue.The root cause is unconfirmed.The issue likely occurred during repackaging with a distributor.Bd will continue to monitor for any trends.

• Brand Name: SHARPS COLL CANADA 3.0L YELLOW
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8655489
• MDR Text Key: 148467977
• Report Number: 2243072-2019-01048
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300450
• Device Lot Number: 9031921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other