MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC; INTRAVASCULAR CATHETER

Catalog Number 383894

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus y 20ga x 1.16in ss prn npvc needle disengagement was difficult.The following information was provided by the initial reporter: on (b)(6) before puncture, check the activity of the core of the indwelling needle is normal, puncture is normal, push the core of the needle is smoother, the flow rate is normal, but when the core of the indwelling needle is retreated to the mouth of the catheter, the inner core sheath tube is stuck in the mouth of the catheter, increase the force and take the inner core at different angles can not be pushed out, try several times to use scissors to cut off the core, the catheter residual part of the inner gas sheath, inform the patient and hand over to the ward, and ask to observe, pull out the indwelling needle as appropriate.The patient was informed of the situation, and the patient and the ward were informed of the situation.

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 3199390, is 20g and product code is 383894, produced on 2023/08, with a total of (b)(4) 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 no sample and provided two videos of the defective sample.From the video, it can be seen that the needle was not deformed.According to the length of the needle seen in the video, the needle had been completely withdrawn, but the tip shield and catheter adaptor are not separated.3.Take the retained sample of this batch for system drag force test, and no abnormality was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: according to the video provided by the customer, the tip shield and catheter adaptor were not separated correctly.It is suspected that the tip shield or the catheter adaptor was damaged, causing the fit between the tip shield and the catheter adaptor to change from clearance fit interference fit, and then this makes it difficult to withdraw the needle.In summary, according to the video analysis provided by the customer, it is suspected that the tip shield or the catheter adaptor was damaged, which makes it difficult to withdraw the needle.Since the customer did not return samples, the specific damage status could not be confirmed, so the root cause of the complaint could not be confirmed.The factory will continue to pay attention to and monitor the trend of defect complaints.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC
• 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: 18994644
• MDR Text Key: 339230901
• Report Number: 3002601200-2024-00107
• 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,Followup
• Report Date: 05/01/2024

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: 383894
• Device Lot Number: 3199390
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1