MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 3ML SYRINGE; PISTON SYRINGE

Catalog Number 990174

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported while using bd plastipak¿ 3ml syringe the plunger fell out.There was no report of patient impact.The following information was provided by the initial reporter: loose syringe plunger, leaking medication, loss of material and risk of contamination with biological material.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary photos received by our quality team for investigation.Through visual evaluation, damaged plunger is observed which likely caused the leakage past stopper.A device history review was performed for the reported lot 2265875, maintenance records related to the failure was identified.Based on the teams investigation, possible root cause is associated with the molding process, due to a chemical reaction of the components of the water used for cooling mold.The lack of refrigeration can cause deformations in the molded component.

Event Description

It was reported while using bd plastipak¿ 3ml syringe the plunger fell out.There was no report of patient impact.The following information was provided by the initial reporter: loose syringe plunger, leaking medication, loss of material and risk of contamination with biological material.

• Brand Name: BD PLASTIPAK¿ 3ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17638043
• MDR Text Key: 322269693
• Report Number: 3003916417-2023-00256
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000347
• UDI-Public: (01)07891463000347
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990174
• Device Lot Number: 2265875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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