MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLLECTOR ECLIPSE 1QT; SHARPS CONTAINER

Catalog Number 367216

Device Problem Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.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.(b)(4).

Event Description

It was reported that sharps collector eclipse 1qt had incorrect lids.The following information was provided by the initial reporter: material no.367216, batch no.0300903.It was reported that customer received sharps collectors with incorrect lids.Customer received sharps collectors with no lids (or incorrect lids).

Event Description

It was reported that sharps collector eclipse 1qt had incorrect lids.The following information was provided by the initial reporter: material no.367216 batch no.0300903.It was reported that customer received sharps collectors with incorrect lids.Customer received sharps collectors with no lids (or incorrect lids).

Manufacturer Narrative

H6: investigation summary: a photo representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like incorrect lid during the manufacturing process of the lot number 0300903.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for incorrect lid for the same part number.This lid shown in picture is not manufactured by flex.According to this investigation, it can be seen that the product was mixed by customer at the time to send the material to the end user, therefore, this issue was confirmed as related to a customer/distribution handling since material from two different suppliers was mixed (flex and covidien product).Root cause is unknown but 2 possibilities are: non-controlled method (re-packaging) to ship partial boxes to end user, or incorrect handling by customer.H3 other text : see h10.

• Brand Name: SHARPS COLLECTOR ECLIPSE 1QT
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11382369
• MDR Text Key: 266944537
• Report Number: 2243072-2021-00613
• 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: 03/24/2021

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: 367216
• Device Lot Number: 0300903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1