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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 Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Investigation summary: it was performed the device history record, quality notification and maintenance analysis and no quality occurrences were observed. We inform for bd products all the production processes are validated according to established criteria to the fulfillment of the users¿ requirements. According to the internal bd procedures for the situation, a research process was initiated involving bd (b)(4) and united states team in order to evaluate the potential causes for the occurrence of the reported defect. As part of this process were opened a corrective and preventative action and situation analysis and are being several activities for a depth analysis of the problem and understanding of their potential causes. According the investigation plan and test results until now, the potential cause to this problem is related to deformity at syringe tip due the production process of the material in molding step. Among the activities planned for the investigation process of the problem are the following evaluations: ¿development of an analytical method to measure the tip circumference deformation with accuracy; ¿include in product draft a specification as to the tip circumference to be monitored during the manufacturing process; ¿parameters and mold changes to guarantee the product specification changes in order to correct tip deformity. As a defined containment action, the inserts were changed in the mold of the syringe cylinder. Investigation conclusion: confirmed: bd was able to confirm/reproduce the incident in question. Samples / photos analysis: the needle samples sent by the customer were analyzed and it was not possible to identify the defect informed. Due to the severity of the problem, it will be considered in the evaluations already performed on complaint samples and functional tests performed with the syringes, which was possible to identify air bubbles defect. Dhr review: it was verified the batch record and the process inspections were performed at properly frequency. Qn review: no quality notification (qn) were found in the batch informed. Maintenance review: no maintenance records were found. Conclusion: it was performed the dhr, quality notification and maintenance analysis and no quality occurrences were observed. As part of this process were opened of the capa # 331654 and situation analysis # 18-1223 and are being several activities for a depth analysis of the problem and understanding of their potential causes. According the investigation plan and test results until now, the potential cause to this problem is related to deformity at syringe tip due the production process of the material in molding step. Root cause description: according to the investigation plan defined and tests results found until this moment, the potential cause for the defect would be related to a deformity in the syringe tip due the production process in molding step. As defined the containment action for this deformation, the inserts were changed in the mold of the syringe barrel, implemented as of july 12, 2018. Rationale: capa #(b)(4) and situation analysis (b)(4).
 
Event Description
It was reported that air got into the bd plastipack¿ syringe during blood collection. There was no report of exposure, injury, or medical intervention.
 
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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
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7806390
MDR Text Key118101807
Report Number3003916417-2018-00210
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990172
Device Lot Number8088858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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