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

Catalog Number 383742

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus pnk 20ga x 1.16in prn-cap y needle disengagement was difficult.The following information was provided by the initial reporter: needle core cannot be withdrawn.

Manufacturer Narrative

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

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review: (1) the packaging batch number of the complained product is 3186537, is 20g and product code is 383742, assembled in the suzhou plant, then packaged and sterilized in the tuas plant in singapore; the related assembly batch number of the product is 3126925, were assembled in 2023/06, the batch of products totaling (b)(4) pieces; (2)inspection process and delivery test report, test results meet product standards, no abnormalities; (3)check the production record of the batch of products, no conformance, deviation or rework activities in the process of the batch of products; 2.The customer did not return any samples or photos,the defect status cannot be confirmed.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.In summary,due to the lack of samples returned by the customer, the specific defect status cannot be confirmed, therefore the root cause of the complaint cannot be confirmed.The factory will continue to monitor the trend of the defect complaint.H3 other text : see narrative.

• Brand Name: BD PEGASUS PNK 20GA X 1.16IN 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18754696
• MDR Text Key: 336757099
• Report Number: 2243072-2024-00193
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837427
• UDI-Public: (01)00382903837427
• 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: 03/29/2024

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: 383742
• Device Lot Number: 3186537
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1