MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL MEXICO 22.7L RED; SHARPS CONTAINER

Catalog Number 300182

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

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: na.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 22.7l red was damaged.The following information was provided by the initial reporter: it was found damaged inside sealed package.

Manufacturer Narrative

H6: investigation summary: photos were received with the customer's complaint of broken lids.This evidence was then forwarded to the supplier for further investigation.The complaint was verified with photo evidence alone.According to the dhr review process, the result showed there were no issues reported like lid broken ¿ damaged during the manufacturing process of the lot number (0168935) reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lids or cracked issue for the same part number (300182) throughout the last twelve months.Without further evidence like physical sample, the root cause of this investigation remains unknown.

Event Description

It was reported that sharps coll mexico 22.7l red was damaged.The following information was provided by the initial reporter: it was found damaged inside sealed package.

• Brand Name: SHARPS COLL MEXICO 22.7L RED
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12017832
• MDR Text Key: 256802230
• Report Number: 2243072-2021-01693
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300182
• Device Lot Number: 0168935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1