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

Catalog Number 383716

Device Problem Break (1069)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported that bd pegasus yel 24gax0.75in prn-capy non-pvc had a broken hose.The following information was provided by the initial reporter, translated from chinese to english: before preparing to administer intravenous fluids to patient on (b)(6) 2023, the indwelling needle tip hose was found to be partially reflexed and broken, making it unusable.Replace the indwelling needle with another model.

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.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3037985, is24g and product code is 383716, produced on 2023/02, 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 any samples or photos, cannot confirm the specific defect status; 3.Take the retained sample of this batch, do catheter tip penetration force test, catheter drag force test, catheter inner diameter and catheter pull test, no found abnormal.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.In summary, due to the customer did not return any samples or photos, the specific defect status cannot be confirmed.Therefore, the root cause of the complaint defect cannot be determined.The factory will continue to pay attention to and monitor the trend of the 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: 18645097
• MDR Text Key: 334956349
• Report Number: 3002601200-2024-00013
• 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: 03/21/2024

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: 383716
• Device Lot Number: 3037985
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1