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

Catalog Number 990172

Device Problems Air Leak (1008); Break (1069)

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8029917.Medical device expiration date: 2023-01-31.Device manufacture date: 2018-01-31.Medical device lot #: 7362762.Medical device expiration date: 2022-12-31.Device manufacture date: 2017-12-28.Medical device lot #: 7362814.Medical device expiration date: 2022-12-31.Device manufacture date: 2017-12-28.

Event Description

It was reported that during use a bd plastipack¿ syringe was found broke as "formation of air bubbles inside the syringe" were found.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: samples/ photos analysis: due to the severity of the problem, the functional tests and evaluations already performed on other complaint samples will be considered.Dhr, quality notification, and maintenance records analysis were carried out and no quality occurrences were observed.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 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.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.Capa #331654 and situation analysis sa #18-1223 are initiated to address the issue.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7574027
• MDR Text Key: 110586468
• Report Number: 3003916417-2018-00103
• 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: 06/11/2018

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 Health Care Professional
• Device Catalogue Number: 990172
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other