MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA 7.6L FUNNEL YELLOW; SHARPS CONTAINER

Catalog Number 300440

Device Problems Device Damaged Prior to Use (2284); Component Missing (2306)

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

Event Date 03/03/2021

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 flextronics.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.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 canada 7.6l funnel yellow was broken and missing the cover.This occurred on 2 occasions.The following information was provided by the initial reporter: 2 of the container were broken.2 of the container has missing cover.

Event Description

It was reported that sharps coll canada 7.6l funnel yellow was broken and missing the cover.This occurred on 2 occasions.The following information was provided by the initial reporter: 2 of the container were broken.2 of the container has missing cover.

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 broken lid during the manufacturing process of the lot number 0236022.A dhr review was performed and showed there were no issues reported like missing lids during the manufacturing process of the lot number 0236022.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for broken lid/missing lids for the same part number.According to this investigation, the image provided clearly showed a broken lid.It was noticed that this product was sold by a distributor (tan tock seng hospital pte ltd-mmd).For this reason, evidence of the packaging used will be needed to determine the root cause.Therefore, due to lack of evidence it can¿t be confirmed this nonconformance as a failure mode related to a manufacturing process, because this kind of damages could be generated due to different variables like transit damaged, inadequate packaging to send the product to the end user.Possible root causes include: non-controlled method to ship partial boxes to end user, product damaged during the shipment or distribution (non-suitable packing), incorrect packaging process at the time to perform partial sales.According with this investigation there is not enough information provided from customer like pictures of original packaging and/or label issued by the weighing system in order to determine the root cause of missing lids.H3 other text : see h.10.

• Brand Name: SHARPS COLL CANADA 7.6L FUNNEL YELLOW
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11586635
• MDR Text Key: 253123596
• Report Number: 2243072-2021-00896
• 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: 04/16/2021

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: 300440
• Device Lot Number: 0236022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1