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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE Back to Search Results
Catalog Number 990174
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 the plunger of the bd plastipak¿ luer-lok¿ syringe was rough during application. Found during use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: the physical samples from the complaint were verified and the retain sample were submitted to validated test for plunger movement, no deviations observed. Thus it is not possible confirm the defect reported at this complaint. Dhr, quality notification and maintenance records were analyzed for the complaint batch 5194466 and no occurrences that potentially related to the defect were found. Based on the severity and occurrence a capa is not required. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the plunger of the bd plastipak¿ luer-lok¿ syringe was rough during application. Found during use. No reports of serious injury or medical intrvention noted.
 
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Brand NameBD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7634526
MDR Text Key112553360
Report Number3003916417-2018-00112
Device Sequence Number1
Product Code FMF
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,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/01/2020
Device Catalogue Number990174
Device Lot Number5194466
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/25/2018 Patient Sequence Number: 1
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