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

Catalog Number 305643

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that sharps coll ii bd 13l was damaged.This was discovered before use.The following information was provided by the initial reporter: we received the (b)(4) where we found that the following product arrived with malfunction.

Manufacturer Narrative

H.6.Investigation: dhr, quality notification and maintenance analysis were performed and no occurrences related to the occurrence was observed.The picture sent by the customer was verified and it was possible observe descartex broken.This occurrence is potentially related to an damage caused during the material transport or feeding.H3 other text : see h.10.

Event Description

It was reported that sharps coll ii bd 7l was damaged.This was discovered before use.The following information was provided by the initial reporter: we received the nf 555249 where we found that the following product arrived with malfunction.

Manufacturer Narrative

The following fields have been updated with corrections/additional information: b.5.Describe event or problem: the event description has been updated with a new medical device brand name.D.1.Medical device brand name: sharps coll ii bd 7l d.2.Medical device catalog #: 305643 d.4.Medical device expiration date: na d.4.Medical device lot #: 0142180 d.4.Unique identifier (udi) #: (b)(4).H.4.Device manufacture date: 2020-05-21.

Event Description

It was reported that sharps coll ii bd 7l was damaged.This was discovered before use.The following information was provided by the initial reporter: we received the nf 555249 where we found that the following product arrived with malfunction.

• 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: 10463495
• MDR Text Key: 206969356
• Report Number: 3003916417-2020-00250
• 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,Followup
• Report Date: 09/18/2020

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: 305643
• Device Lot Number: 0142180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 08/07/2020
• Supplement Dates FDA Received: 09/17/2020; 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other