MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS BL 22GA X 1.00IN PRN-CAP Y; INTRAVASCULAR CATHETER

Catalog Number 383932

Device Problem Retraction Problem (1536)

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

Event Date 01/22/2024

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 four bd pegasus bl 22ga x 1.00in prn-cap y needles were difficult to disengage.The following information was provided by the initial reporter, translated from chinese to english: sales call reported that feima puncture is not easy, the needle is curved/it is difficult to withdraw the needle core.

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3234091, is 22g and product code is 383932, produced on 2023/09, 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 for needle penetration force test,catheter tip penetration force test,catheter drag force and system drag force test, no found abnormal, 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.In summary, the root cause of the complaint defect cannot be confirmed, and 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 BL 22GA X 1.00IN PRN-CAP Y
• 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: 18663552
• MDR Text Key: 334849181
• Report Number: 3002601200-2024-00023
• 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: 03/25/2024

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: 383932
• Device Lot Number: 3234091
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1