MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CAN 22.7L YEL 1103 VENT CAP; SHARPS CONTAINER

Catalog Number 300434

Device Problems Device Damaged Prior to Use (2284); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).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.Initial reporter phone #: (b)(6).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 sharps coll can 22.7l yel 1103 vent cap experienced 3 cases of broken/damaged lids, and a case of damaged/deformed product while still considered operable.The following information was provided by the initial reporter: material no: 309680n.Batch no: 0338922.Out of box damaged, as per customer.I just had a chance to put away my order, and i noticed that 3 lids and 1 sharp containers were broken and unusable.

Manufacturer Narrative

H6: investigation summary no photos or samples were received of the actual affected sharps containers with the customer's complaint of lid/bases broken.Without a physical sample or photos of the sharps and or the packaging which led to the failure, the root cause remains unknown.According to the dhr review process, the result showed there were no issues reported like base broken - damage during the manufacturing process of the lot 0338922 reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like base broken - damage issue for the same part number throughout the last twelve months.H3 other text : see h10.

Event Description

It was reported that sharps coll can 22.7l yel 1103 vent cap experienced 3 cases of broken/damaged lids, and a case of damaged/deformed product while still considered operable.The following information was provided by the initial reporter: material no: 309680n batch no: 0338922.Out of box damaged, as per customer.I just had a chance to put away my order, and i noticed that 3 lids and 1 sharp containers were broken and unusable.

• Brand Name: SHARPS COLL CAN 22.7L YEL 1103 VENT CAP
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11971665
• MDR Text Key: 255993905
• Report Number: 2243072-2021-01658
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300434
• Device Lot Number: 0338922
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1