MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SHARPS COLL II BD 7L; SHARPS CONTAINER

Catalog Number 305643

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 4 sharps coll ii bd 7l experienced missing lid or slide lid/clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: it was observed a non-conformity when opening the box of collector bd descartex ii of 7 l - product code 305643, which it has come missing 4 collectors' covers/lids, making not possible to use them.

Manufacturer Narrative

H.6.Investigation: dhr, quality notification and maintenance analysis were performed and no occurrences potentially related to the incident were observed.The customer report and image provided were verified and it was possible to observe short count.The potential cause for the reported incident is operational failure at manual packaging machine.The operators will be notified from this complaint.

Event Description

It was reported that 4 sharps coll ii bd 7l experienced missing lid or slide lid/clamp.Product defect was noted prior to use.The following information was provided by the initial reporter: it was observed a non-conformity when opening the box of collector bd descartex ii of 7 l - product code 305643, which it has come missing 4 collectors' covers/lids, making not possible to use them.

• Brand Name: SHARPS COLL II BD 7L
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 10012384
• MDR Text Key: 204057237
• Report Number: 3003916417-2020-00133
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305643
• Device Lot Number: 0021502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other