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

Catalog Number 990172

Device Problems Filling Problem (1233); No Pressure (2994)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation: sample received at bd from customer.Batch history analysis was performed, quality notifications and maintenance records verified, and no deviation was found for this batch.Quality has previously reviewed, evaluated and investigated this failure mode, the appropriate personnel have been notified and are looking further into this issue.A situation analysis, and capa (corrective and preventative action) have been opened to further investigate this issue and implement the appropriate corrective actions.Bd was able to confirm the customer¿s indicated failure.

Event Description

It was reported that a bd plastipak¿ luer-lok¿ syringe had ¿no pressure to pull blood¿.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

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 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 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.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 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.Capa #(b)(4) and situation analysis sa #(b)(4).

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7487643
• MDR Text Key: 107703824
• Report Number: 3003916417-2018-00069
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 990172
• Device Lot Number: 7327572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other