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

Catalog Number 990172

Device Problem Gas/Air Leak (2946)

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

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 there was difficulty aspirating with the bd plastipak¿ syringe luer-lok¿ due to air bubbles forming within during use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

The needles samples sent by the customer were analyzed and it was not possible identify the defect reported.Device history record, quality notification and maintenance records were analyzed and no quality occurrences were observed.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 sa #18-1223 were initiated and are utilizing 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 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 (b)(6) 2018.

Event Description

It was reported there was difficulty aspirating with the bd plastipak syringe luer-lok due to air bubbles forming within during use.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported there was difficulty aspirating with the bd plastipak syringe luer-lok due to air bubbles forming within during use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

• 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: 7738833
• MDR Text Key: 115771454
• Report Number: 3003916417-2018-00178
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000378
• UDI-Public: 7891463000378
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8057712
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 07/10/2018
• Supplement Dates FDA Received: 08/24/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other