MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD PEGASUS INTRAVENOUS CATHETER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383904

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

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that bd pegasus intravenous catheter had a foreign matter on the needle.The following information was provided by the client: "on (b)(6) 2022,a foreign body was found at the needle during puncture, so it was replaced immediately without causing harm to the patient".

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

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

Event Description

It was reported that bd pegasus intravenous catheter had a foreign matter on the needle.The following information was provided by the client: "on (b)(6) 2022,a foreign body was found at the needle during puncture, so it was replaced immediately without causing harm to the patient".

Event Description

It was reported that bd pegasus intravenous catheter had a foreign matter on the needle.The following information was provided by the client: "on 2022.1.20,a foreign body was found at the needle during puncture, so it was replaced immediately without causing harm to the patient".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 1138627.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

• Brand Name: BD PEGASUS INTRAVENOUS CATHETER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13625644
• MDR Text Key: 286330902
• Report Number: 3006948883-2022-00043
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383904
• Device Lot Number: 1138627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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