MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383912

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system experienced black foreign body in the y-connector pipe.The following information was provided by the initial reporter: when opening the package, it was found that there was a black foreign body in the y-connector pipe.

Manufacturer Narrative

Device evaluated by mfr: 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: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 08-sep-2022.H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2049650.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.Additionally, a sample was submitted to our facility for review.Our engineers have noted that the packaging of the returned unit was opened, and identified a small quantity of foreign material on the device.This event has been confirmed.Unfortunately the foreign material was too small to obtain a positive identification through composition testing.Based on the available resources our engineers were not able to associate this issue with the manufacturing process.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system experienced black foreign body in the y-connector pipe.The following information was provided by the initial reporter: when opening the package, it was found that there was a black foreign body in the y-connector pipe.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15311195
• MDR Text Key: 298787555
• Report Number: 3014704491-2022-00378
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383912
• Device Lot Number: 2049650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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