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

Catalog Number 990172

Device Problems Volume Accuracy Problem (1675); Gas/Air Leak (2946)

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

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipack¿ syringe contained air bubbles or volumetric inaccuracy.No serious injury or medical intervention was reported.

Manufacturer Narrative

Sample and photos were returned for evaluation.Device history record, quality notification and maintenance analysis records were reviewed and no quality notifications were observed.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.According to the internal bd procedures for the situation, a research process was initiated involving (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.

Event Description

It was reported that bd plastipack syringe contained air bubbles or volumetric inaccuracy.No serious injury or medical intervention was reported.

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that air bubbles in the syringe for testing is considered to be a reportable event.The following information has been updated: describe event or problem: it was reported that air entered into the bd plastipack¿ syringe while drawing up blood.After investigation, it was determined that this cause resulted due to syringe tip deformity from the production process.The following information was provided by the initial reporter, translated from portuguese to english: "during the blood collect is entering air together with blood.There are cases that it is necessary to puncture the patient one more time.".

Event Description

It was reported that air entered into the bd plastipack¿ syringe while drawing up blood.After investigation, it was determined that the air bubble malfunction resulted due to syringe tip deformity from the production process.The following information was provided by the initial reporter, translated from portuguese to english: "during the blood collect is entering air together with blood.There are cases that it is necessary to puncture the patient one more time.".

Event Description

It was reported that bd plastipack¿ syringe contained air bubbles or volumetric inaccuracy.No serious injury or medical intervention was reported.

Manufacturer Narrative

Correction: the complaint information was revaluated and no longer meets our reporting criteria per cpr-051 guidelines.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8051820
• MDR Text Key: 126658091
• Report Number: 3003916417-2018-00309
• Device Sequence Number: 0
• Product Code: FMF
• 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,Followup
• Report Date: 04/12/2019
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8148741
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 10/19/2018; 10/19/2018
• Supplement Dates FDA Received: 12/18/2018; 04/08/2019; 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other