MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 19GAL SLIDE RCRA; SHARPS CONTAINER

Catalog Number 305072

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that sharps coll 19gal slide rcra was cracked.The following information was provided by the initial reporter: material no: 305072 batch no: unknown.It was reported that the product is cracked.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 11/16/2020 h.6.Investigation: a sample and photo representation was provided, and additional evidence of original packaging to confirm the issue was available.A non-conforming material report (ncmr) review was performed for the past 12 months and there were no manufacturing or material defects reported that could have caused or contributed to the reported incident.An investigation was performed to review the current manufacturing processes.All material is 100% inspected by the production department.Also, a second inspection is performed based on an aql sampling plan by a quality auditor.There are currently controls in place that prevent this from occurring.It is most likely that the damage occurred after distribution and was damaged in transit during shipping or handling by a distributor.

Event Description

It was reported that sharps coll 19gal slide rcra was cracked.The following information was provided by the initial reporter: material no: 305072 batch no: unknown it was reported that the product is cracked.

• Brand Name: SHARPS COLL 19GAL SLIDE RCRA
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10954354
• MDR Text Key: 221293661
• Report Number: 2243072-2020-02009
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305072
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1