MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383716

Device Problem Leak/Splash (1354)

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

Event Date 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd pegasus yel 24gax0.75in prn-capy non-pvc leaked.The following information was provided by the initial reporter, translated from chinese to english: the outpatient teacher reported that during use of the product, leakage occurred near the isolation plug.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3108309, is 24g and product code is 383716, produced on 2023/05, 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 returned a sample, as shown in attached photos 1 and 2.Observed the septum under microscope and no abnormalities were found, as shown in attached photos 3 and 4; take the returned sample do 45psi system leakage test, and no liquid leakage was found, as shown in the attached video 5.3.Take the retained sample of this batch for 45psi system leakage 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) damage to the septum from the raw material damage or septum damaged during the septum assembly process can result in leakage after the needle is removed, which can cause persistent leakage.(2) in the process of needle removal, too slow needle removal speed will lead to a drop of blood from the tail of the septum when the needle is removed, but the product will not continue to leakage.In this case, the needle can be removed at normal speed to avoid it ; (3) if the patient's arm is tied tight during the puncture, it will cause great pressure in the blood vessel, and blood will come out with the needle when the needle is removed, but the subsequent blood leakage will not be sustained.In summary: did not find any abnormalities in the returned samples.Take the returned sample for 45psi leakage test, and no liquid leakage was found.Therefore, the root cause of the complaint defect cannot be determined.The factory will continue to monitor and monitor the trend of this defect complaint.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC
• 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: 18803394
• MDR Text Key: 336631167
• Report Number: 3002601200-2024-00061
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383716
• Device Lot Number: 3108309
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1