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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPACK¿ SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPACK¿ SYRINGE Back to Search Results
Catalog Number 990172
Device Problems Bent (1059); Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. 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 bd plastipack¿ syringe product came with the stopper bent, making it impossible to be used. Found before use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: samples/ photos analysis: a sample was received, and it is possible to observe stopper damaged. Dhr review: it was verified the batch record and the manufacturing date for this batch was november 21th to 22th, 2017. The process inspections were performed at properly frequency and no records of this defect were found. The current controls at manufacturing process to detect the defect are performed by visual inspection with each 2 hours at 36 parts at assembly machine; qn review: no quality notification (qn) that could related to defect were observed. Maintenance review: no maintenance record related to the defect was observed. The probable cause for the defect is related to material jam at syringes assembly machine, causing the stopper defective, allowing the damage product flow of the process. As containment action it was opened the maintenance order sap#(b)(4) to verify the assembly machine. As corrective action it was performed the blitz#57/2018 to damaged components and the actions will be implemented until sep/2018. Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question. Material jam at syringes assembly machine.
 
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Brand NameBD PLASTIPACK¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7636563
MDR Text Key112449209
Report Number3003916417-2018-00113
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/27/2018
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 Catalogue Number990172
Device Lot Number8088799
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
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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