MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; INTRAVASCULAR CATHETER

Catalog Number 383904

Device Problem Mechanical Problem (1384)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus y 24ga x 0.75in ss prn npvc needle disengagment was difficult the following information was provided by the initial reporter: nurse supervisor reported that the product was found to be difficult to withdraw the needle core during use to the patient, completely unable to withdraw the core, number of units affected 1 unit, green claim required, complaint response letter required, complaint acceptance letter not required, photographs available, samples could not be returned.

Manufacturer Narrative

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

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3247503, is 24g and product code is 383904,produced on 2023 (b)(6), with a total of 96000 pieces 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 did not return sample, only provided a photo of the defective sample.From the photo, it can be seen that the tip shield and catheter adaptor were not successfully separated, and the needle core was severely deformed.3.Take the retained sample of this batch for system drag force test, and no abnormality was found.Test report refer to attachment 1.4.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 photo provided by the customer, the product has been used and the needle has been severely deformed.It is suspected that the difficulty in withdrawing the needle is due to the deformation of the needle; 2) this product is produced on automatic line, at the zone4 c20 s3.4 needle insertion septum station.Due to poor alignment of the equipment grippers or poor cutting of the septum, the needle may deform at a small angle when inserting the septum; 3) at the next workstation zone4 c20 s7, the needle is inserted into the paddle hub, washer, and tip shield assembly, due to poor alignment of the device gripper, causing greater deformation of the needle and resulting in increased needle system drag force.Corrective action: the technician optimized and adjusted the alignment of the zone4 c20 s3.4 and s7 station grippers in december 2023.The maintenance records are attached in attachment 1, currently under continuous monitoring.In summary, the direct cause of the complaint defect is suspected to be due to the deformation of the needle core, resulting in difficulty in withdrawing the needle; the root cause for the defect in this complaint is that at the zone4 c20 s3.4 needle insertion septum station.Due to poor alignment of the equipment grippers or poor cutting of the septum, the needle may deform at a small angle when inserting the septum.Then at the next workstation zone4 c20 s7, the needle is inserted into the paddle hub, washer, and tip shield assembly, causing greater deformation of the needle and resulting in increased needle system drag force.The factory has taken relevant improvement actions and will continue to pay attention to and monitor the trend of defect complaints.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18566796
• MDR Text Key: 333536384
• Report Number: 3014704491-2024-00029
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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: 383904
• Device Lot Number: 3247503
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1