MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CAN 1.4L YEL FUNNEL VENT CAP; SHARPS CONTAINER

Catalog Number 300460

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the sharps coll can 1.4l yel funnel vent cap lid did not stay closed and opened on its own.When pressing on the lid "very hard", it would close, but was "impossible" to reopen with the tab, and the nurse had to use their nails to pry it open.The following information was provided by the initial reporter, translated from (b)(6) to english: "a home care nurse complained that the lid did not stay closed and opened on its own.When i close the cover and hear 1 click, the cover will reopen by itself after 1 second.When i press very hard and i hear 2 clicks, it closes well but it is impossible to reopen with the tab.I managed to open it with my nails which is not feasible for a field nurse with short nails and gloves.".

Event Description

It was reported that the sharps coll can 1.4l yel funnel vent cap lid did not stay closed and opened on its own.When pressing on the lid "very hard", it would close, but was "impossible" to reopen with the tab, and the nurse had to use their nails to pry it open.The following information was provided by the initial reporter, translated from french to english: "a home care nurse complained that the lid did not stay closed and opened on its own.When i close the cover and hear 1 click, the cover will reopen by itself after 1 second.When i press very hard and i hear 2 clicks, it closes well but it is impossible to reopen with the tab.I managed to open it with my nails which is not feasible for a field nurse with short nails and gloves".

Manufacturer Narrative

H.6.Investigation: a sample or picture evidence was not provided for investigation.An investigation was completed for the issue of lid will not stay closed and opened on its own with the limited information provided.A dhr review showed there were no issues observed during the production of this lot.All testing was within specification and no non-conformances were identified.According with this investigation the failure mode appears to be unconfirmed and inconclusive as it was not determined to be related to any manufacturing process.Additional evidence like pictures or a video are required for any further investigation to determine any other possible root cause.The root cause for the complaint is unknown.H3 other text : see h.10.

• Brand Name: SHARPS COLL CAN 1.4L YEL FUNNEL VENT CAP
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10302056
• MDR Text Key: 200692080
• Report Number: 2243072-2020-01092
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300460
• Device Lot Number: 0020001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other