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

Catalog Number 990256

Device Problem Failure to Deliver (2338)

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

Event Date 05/25/2022

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Investigation summary: 1 ml syringe batch history analyzes (dhr) were performed, maintenance records were verified, and no quality notifications related to the incident were found.Photos/samples were not made available by the customer for evaluation, and it was not possible to carry out an investigation and determine the root cause for the incident.Therefore, it is not possible to confirm the claim.The production processes are validated in accordance with the defined acceptance criteria, and as the defect rate does not exceed the lqa for the batch, no corrective or preventive action is proposed within the scope of this claim.3 ml syringe as no information was provided regarding the product, batch or any identifier, batch history analyzes (dhr) were not performed.Photos/samples were not made available by the customer for evaluation, and it was not possible to carry out an investigation and determine the root cause for the incident.Therefore, it is not possible to confirm the claim.The production processes are validated in accordance with the defined acceptance criteria, and as the defect rate does not exceed the lqa for the batch, no corrective or preventive action is proposed within the scope of this claim.

Event Description

It was reported by the customer that during use, the bd plastipak¿ insulin syringe was very hard, blocking, and making it difficult to collect blood and apply medication.The following information was provided by the initial reporter and translated from portuguese: dissatisfaction with 1ml and 3ml bd syringes from bd brand.They are very hard, blocking, making it difficult to collect blood and apply medication.

• Brand Name: BD PLASTIPAK¿ INSULIN SYRINGE
• Type of Device: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14786758
• MDR Text Key: 300343183
• Report Number: 3003916417-2022-00094
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990256
• Device Lot Number: 1357460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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