MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL MEXICO PUD RED; SHARPS COLLECTOR

Catalog Number 300183

Device Problems Break (1069); Component Missing (2306)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is flextronics.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.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that sharps coll mexico pud red come with no lids or are damaged.No serious injury or medical intervention was reported.

Event Description

It was reported that sharps coll mexico pud red come with no lids or are damaged.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: a sample was available and photo of the issue with two containers missing lids was taken to confirm the issue.A review of the device history record (dhr) for the reported lot and a review of the 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.However, an improvement action had already been identified in the manufacturing process and corrective and preventive actions are in process to avoid or reduce the recurrences for missing lids.A weight system will be implemented that provides a weighted label that confirms each final box before shipment.Based on these findings, the root cause was due to the packaging method which is a manual counting process.Bd will continue to monitor for any trends.

• Brand Name: SHARPS COLL MEXICO PUD RED
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8180389
• MDR Text Key: 131138177
• Report Number: 2243072-2018-01847
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300183
• Device Lot Number: 8083914
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other