MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿; INTRAVASCULAR CATHETER

Catalog Number 383718

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/25/2021

Event Type  malfunction  

Event Description

It was reported that septum discoloration occurred on bd pegasus¿ safety closed iv catheter system with q-syte¿.This event occurred 2 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "not used, found diaphragm yellowing.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation: yes.D10: returned to manufacturer on: 2021-12-21.H6: investigation summary: aa device history review was conducted for lot number 9106518.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Two samples were submitted to aid in our investigation.Our engineers noted one sample was returned in a sealed packaging unit and that both devices exhibited yellowing of the qsyte septum.The issue has been confirmed.Additionally, the retention samples were reviewed by our engineers.The retained samples did not exhibit similar yellowing of the septum.Based on the available results our engineers have concluded that the most likely root cause is related to environmental exposure during shipping or storage.Exposure to uv light can cause a yellowing effect on the raw material of the qsyte septum.Bd recommends reviewing local storage environment for potential exposure.

Event Description

It was reported that septum discoloration occurred on bd pegasus¿ safety closed iv catheter system with q-syte¿.This event occurred 2 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: "not used, found diaphragm yellowing.".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13064514
• MDR Text Key: 285608435
• Report Number: 3014704491-2021-00381
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 383718
• Device Lot Number: 9106518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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