MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿

Catalog Number 990175

Device Problem Air Leak (1008)

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

Event Date 05/22/2018

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 during use a bd plastipak¿ syringe luer-lok¿was found with "the formation of air bubbles inside the syringe." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Samples/ photos analysis: the needles samples sent by the customer were analyzed and it was not possible to identify the defect.Due to the severity of the problem, bd will consider 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.Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question.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 brazil and united states team in order to evaluate the potential causes for the occurrence of the reported defect.As part of this process, capa # 331654 and situation analysis # 18-1223 were opened 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.Investigation conclusion: according the investigation plan and test results until now, the potential cause to this problem is related to deformity at syringe tip due to the production process of the material in the molding step.

• 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 Key: 7574005
• MDR Text Key: 110463392
• Report Number: 3003916417-2018-00104
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 990175
• Device Lot Number: 7361553
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other