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

Catalog Number 990172

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).Investigation summary: it was performed the dhr, 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) team in order to evaluate the potential causes for the occurrence of the reported defect.As part of this process a corrective and preventative action was opened 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.Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question.Samples/ photos analysis: due to the severity of the problem, will be considered the evaluations already performed on complaint samples and functional tests performed.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 record were found.Conclusion: it was performed the dhr, 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) team in order to evaluate the potential causes for the occurrence of the reported defect.As part of this process were opened of the capa #: (b)(4) and situation analysis #: (b)(4) 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.Rationale: capa #: (b)(4) and situation analysis sa #: (b)(4).

Event Description

It was reported that during draw of the patient, and aspiration of the bd plastipack¿ syringe product.Air bubbles are formed inside the tube, making the sample un-viable.Found during use.No reports of serious injury or medical intervention noted.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: SYRINGE
• 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 Key: 7635136
• MDR Text Key: 112553947
• Report Number: 3003916417-2018-00122
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 990172
• Device Lot Number: 7193579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other