Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SHARPS COLL II BD 7L; SHARPS CONTAINER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON IND. CIRURGICAS LTDA BD SHARPS COLL II BD 7L; SHARPS CONTAINER Back to Search Results
Catalog Number 305643
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 before use of the bd sharps coll ii bd 7l the label information was missing on one side of the product.The following information was provided by the initial reporter, translated from portuguese to english: missing label in the product.
 
Event Description
It was reported that before use of the bd sharps coll ii bd 7l the label information was missing on one side of the product.The following information was provided by the initial reporter, translated from portuguese to english: missing label in the product.
 
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 to observe label missing.This occurrence is potentially related to an operational failure during manual label application.H3 other text : see h.10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD 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 Key9292669
MDR Text Key194844265
Report Number3003916417-2019-00565
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305643
Device Lot Number8205571
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-