MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS NESTABLE COLLECTOR 7.6L (6.7QT); SHARPS COLLECTOR

Catalog Number 300440

Device Problems Unintended Ejection (1234); Device Markings/Labelling Problem (2911)

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

Event Date 07/22/2018

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed in as (b)(4) is an oem manufacturing site.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 Description

It was reported that the bd¿ sharps nestable collector 7.6l (6.7qt) had label defects including print quality, air bubbles, missing labels, and double label.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that the bd sharps nestable collector 7.6l (6.7qt) had label defects including print quality, air bubbles, missing labels, and double label.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Photographs were returned in support of this complaint.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.According to this investigation and information provided from customer, it was confirmed that these labeling issues are related to manufacturing process, the current process controls were reviewed, and it was found that all material shall be inspected by the production personnel; additionally a second inspection based on aql sampling plan is performed by the quality inspector.Investigation conclusion: based on this investigation the root cause was confirmed like a failure mode related to the manufacturing process and in accordance to risk assessment results, corrective actions are required.For this reason, a capa record was opened to perform an exhaustive investigation as well to implement corrective action to eliminate or minimize the probabilities of recurrences.All the complaint information was captured for tracking and trending purposes.Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

• Brand Name: BD¿ SHARPS NESTABLE COLLECTOR 7.6L (6.7QT)
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7774634
• MDR Text Key: 117008420
• Report Number: 2243072-2018-01042
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300440
• Device Lot Number: 6334923
• Date Manufacturer Received: 07/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other