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

Catalog Number 990687

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

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 before use of the bd plastipak luer-lok syringe when aspirating with the device the stopper of the plunger detached, the plunger became loose.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: dhr review: the batch complained was manufacturing in dec/2017.The inspections carried out on the moij34 injection machine were checked and records of pressure variation were found which results in the defect presented in the part.Besides that, in qns (quality notification) reports were found occurrences of plunger failed for the two batches used to produce the syringe ((b)(4)).Please be advised that the current controls for detecting the defect are performed by visual inspection with 4x per turn in 1 cycle of parts.Qn/ maintenance review: there are quality notification (qn) and maintenance report records that could lead to this issue for the batches involved in this complaint.A sample was returned for evaluation.The sample sent by the customer was verified and it was possible to confirm plunger failed defect.Conclusion: the probable cause for the defect is related to pressure variation in the machine that this product is manufactured on.To correct the defect, the machine will undergo a process of reform of the entire electrical, hydraulic and pneumatic system until(b)(6) 2018, according to the project retrofit moij34.The root cause of this defect is the pressure variation of the injection machine.When this problem occurs, the plastic material can not arrive at the end of the mold cavity, causing failed parts (without plastic).Therefore, to correct the defect, a machine reform has been initiated to eliminate the problem with pressure variation.Based on the severity, occurrence and quality data analysis for this product family a capa is not necessary.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7245339
• MDR Text Key: 99360429
• Report Number: 3003916417-2018-00009
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 990687
• Device Lot Number: 7333845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other