MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 301229

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo received for investigation, upon visual inspection of the picture from lot 2006206 it can be observed a hair across the blister of the device.This suggest, the hair fell during packaging process, as it is located between film and paper of unitary packaging.A device history review was performed for reported lot 2006206, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly station has a de-ionizer and vacuum system used to remove any particles inside the barrel.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.The areas where pieces run in manufacturing area are protected to avoid damage on the product and reduce particles from generating.While we cannot identify a direct issue, possible root cause is human error.Manufacturing personnel have been notified of this incident to increase awareness of this matter.A project was initiated to reduce any foreign matter inside our products.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported when using the bd plastipak¿ luer-lok¿ syringe, the device experienced sterility issues (product not sterile).The following information was provided by the initial reporter.The customer stated: sealed hair in packaging.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12746670
• MDR Text Key: 284839579
• Report Number: 3003152976-2021-00726
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301229
• Device Lot Number: 2006206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1