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

Catalog Number 990172

Device Problem Gas/Air Leak (2946)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.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 defined the containment action for this deformation, the inserts were changed in the mold of the syringe barrel.Investigation conclusion - confirmed: bd was able to confirm/ reproduce the incident in question.2 - samples/ photos analysis: the needles samples sent by the customer were analyzed and it was not possible identify the defect informed.Due to the severity of the problem, will be considered the evaluations already performed on complaint samples and functional tests performed with the syringes, which was possible to identify air bubbles defect.3 - dhr review: it was verified the batch record and the process inspections were performed at properly frequency.4- qn review: no quality notification (qn) were found in the batch informed.5 - maintenance review: no maintenance record were found.6 - 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) 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 of the capa # (b)(4) and situation analysis # 18-1223 and are being several activities for a depth analysis of the problem and understanding of their potential causes.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 the tip deformity.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.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.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 the situation analysis sa# (b)(4).

Event Description

It was reported that during use of the bd plastipack¿ syringe, was having problems with the stopper since there was a lot of air coming in and making bubbles.There was no report of exposure, injury, or medical intervention.

• 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: 7843692
• MDR Text Key: 119378086
• Report Number: 3003916417-2018-00215
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8115511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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