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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿
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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿ Back to Search Results
Catalog Number 990172
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 09/17/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8177918; medical device expiration date: 2023-06-30; device manufacture date: 2018-06-29; medical device lot #: 8148726; medical device expiration date: 2023-05-31; device manufacture date: 2018-05-30; medical device lot #: 8115520; medical device expiration date: 2023-04-30; device manufacture date: 2018-05-02.(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 during use of the bd plastipak¿ syringe luer-lok¿ when pressure was applied to the plunger medication leaked out spraying the drug on the face of the health care professional.The health care professional was referred for medical follow-up and laboratory exams were performed.
 
Manufacturer Narrative
Investigation summary: dhr evaluation of reported batches, maintenance record analysis and quality notification analysis were carried out and no deviations were found for these batches.The samples sent by the customer were submitted to validation test and no deviation was observed.The manufacturing process are validated with defined acceptance criteria.From the available information it is not possible confirm the complaint.The defect reported by this complaint will be monitored to tendency analysis.
 
Event Description
It was reported that during use of the bd plastipak¿ syringe luer-lok¿ when pressure was applied to the plunger medication leaked out spraying the drug on the face of the health care professional.The health care professional was referred for medical follow-up and laboratory exams were performed.
 
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Brand Name
BD PLASTIPAK¿ SYRINGE LUER-LOK¿
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7949483
MDR Text Key123191243
Report Number3003916417-2018-00255
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,health professional,o
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number990172
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Date Manufacturer Received09/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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