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

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unknown bd pegasus needle disengagement was difficult the following information was provided by the initial reporter: intravenous indwelling needle cartridges cannot be withdrawn after a patient's iv puncture.

Manufacturer Narrative

1.Dhr/bhr review: 1-the batch number of the complained product is 2080999, is 22g and product code is 383728,produced on 2022/04, with a total of (b)(4) in this batch; 2-inspection process inspection and delivery inspection report, the test results meet the product standards, no abnormality; 3-check the production records for this batch of products that there are no nonconformities, deviations or rework activities in the process of this batch of products; 2.The customer returned a sample that has been used, as shown in the attached photo 1-2; done the pull test on the sample, and the needle could not be pulled after being pulled out a certain distance, as shown in the attached video 3-4.Based on the test condition, it is suspected that the needle was damaged, which caused difficulty in withdrawing the needle.; take out the sample needle and observe it under microscope.It is found that there are two damages in the middle of the needle, as shown in the attached photos 5-6,measure the size of the damaged location of the needle, it was 0.565mm, as shown in the attached photo 7.3.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.Cause analysis: 1- according to the analysis of samples returned by the customer, it was confirmed that the outer diameter of the needle was enlarged due to damage to the needle, which exceeded the needle size specification , and the fit with the washer hole became an interference fit, making it difficult to withdraw the needle; 2- based on the distance from the damaged position of the needle to the needle tip, and comparing it with the grippers of the on-site equipment, it was confirmed that the needle was pinched by the grippers of the automatic line station.If the pressure to control the opening and closing of the grippers increases, the needle may be pinched.Corrective action: the technician re-calibrated and confirmed the pressure gauge of the automatic line station gripper in may 2024 to control the gripper pressure within the required range, and adding pressure check to every shift.In summary, based on the analysis of the sample returned by the customer, it was confirmed that the cause of the defect was due to the increased pressure of the gripper at the station of the automatic line, which pinched the needle and made it difficult to withdraw the needle.The factory has taken relevant improvement measures and will continue to pay attention to and monitor the trend of defect complaints.

Event Description

Mat#: 383728, lot # 2080999; was identified on (b)(6) when the device was investigated.No additional information provided.

• Brand Name: UNKNOWN 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 (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19045874
• MDR Text Key: 340110139
• Report Number: 3002601200-2024-00121
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• 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
• Report Date: 03/18/2024

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• 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