MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 22.7L YEL AU 1508 NON-VENT; SHARPS COLLECTOR

Catalog Number 300740

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8134935, medical device expiration date: na, device manufacture date: 2018-05-21, medical device lot #: 8134935, medical device expiration date: na, device manufacture date: 2018-05-21, medical device lot #: 0187933 (this is an invalid lot #), medical device expiration date: na, device manufacture date: na, medical device lot #: 0118912 (this is an invalid lot #), medical device expiration date: na, device manufacture date: na.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 11 sharps coll 22.7l yel au 1508 non-vent experienced broken/damaged lids.The following information was provided by the initial reporter: damaged lids.When the carton was opened the customer noticed the lids we damaged and the product was not able to be used.

Manufacturer Narrative

H.6.Investigation: 1 photo representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like lid broken/damaged during the manufacturing process of the lot numbers provided.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for lid broken/damaged for the same part number.According with this investigation and information provided from the customer (picture) there is not enough information provided like pictures of packaging used to send material to the end user.As part of this investigation it was also noticed that a lot number reported under this complaint was manufactured in may of 2018, that¿s why the controls used to handle to material, storage, and packaging used to ship material to the end user are needed to determine the root cause of this issue.In addition, the current manufacturing controls were reviewed, and they were confirmed as capable to detect this kind of issues (damaged lid).Root cause unknown at this time with the information provided.

Event Description

It was reported that 11 sharps coll 22.7l yel au 1508 non-vent experienced broken/damaged lids.The following information was provided by the initial reporter: damaged lids.When the carton was opened the customer noticed the lids we damaged and the product was not able to be used.

• Brand Name: SHARPS COLL 22.7L YEL AU 1508 NON-VENT
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11665461
• MDR Text Key: 245392972
• Report Number: 2243072-2021-01109
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300740
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1