MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CAN 22.7L YEL 1102 VENT CAP; SHARPS CONTAINER

Catalog Number 300483

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: (b)(4).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0044924, medical device expiration date: na, device manufacture date: 2020-03-03, medical device lot #: 9206944, medical device expiration date: na, device manufacture date: 2019-08-12.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 5 sharps coll can 22.7l yel 1102 vent cap lids from lot 9206944, and an unspecified number of lids from lot 0044924 were found broken in the box before use.The following information was provided by the initial reporter: "5 lids out of 12 in the case that where already broken in the box.".

Event Description

It was reported that 5 sharps coll can 22.7l yel 1102 vent cap lids from lot 9206944, and an unspecified number of lids from lot 0044924 were found broken in the box before use.The following information was provided by the initial reporter: "5 lids out of 12 in the case that where already broken in the box.".

Manufacturer Narrative

H.6.Investigation: a sample and photo representation was not provided, and additional evidence of original packaging to confirm was not available.A review of the device history record (dhr) could not be performed as the lot was unknown.A non-conforming material report (ncmr) review for the reported lot was performed for the past 12 months and there were no manufacturing or material defects reported that could have caused or contributed to the reported incident.An investigation was performed to review the current manufacturing processes.All material is 100% inspected by the production department.Also, a second inspection is performed based on an aql sampling plan by a quality auditor.H3 other text : see h.10.

• Brand Name: SHARPS COLL CAN 22.7L YEL 1102 VENT CAP
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10428787
• MDR Text Key: 205330436
• Report Number: 2243072-2020-01281
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: 300483
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other