MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

D.The lot number 00382903837182 provided have not been found and cannot be verified.D.4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that a bd pegasus had difficulty disengaging the needle.The following information was provided by the initial reporter, translated from chinese to english: the nurse performed an iv infusion for a patient and punctured the patient with the product's indwelling needle; the puncture failed due to the difficulty of withdrawing the needle core, so a second puncture was performed.

Manufacturer Narrative

A complaint history review cannot be performed as no material and batch/lot number was provided.A device history record(dhr) review could not be performed as no material and batch/lot number was made available for this reported event.A retain sample analysis review could not be performed as no material and batch/lot number was made available for this reported event.A review of the applicable d-eura  indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause couldn't be determined due to unavailability of sample, material and batch/lot number information.H3 other text : see narrative.

• Brand Name: BD PEGASUS
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18813605
• MDR Text Key: 336745224
• Report Number: 3002601200-2024-00066
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1