MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383736

Device Problem Difficult to Remove (1528)

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

Event Date 02/01/2024

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 100 bd pegasus bl 22gax1.00in prn-cap y non-pvc was difficult to disengage the needle.The following information was provided by the initial reporter, translated from chinese to english: it is difficult to withdraw the indwelling needle and it is very astringent.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3108270, is 22g and product code is 383736, 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 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.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.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS BL 22GAX1.00IN PRN-CAP Y 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: 18803538
• MDR Text Key: 336517973
• Report Number: 3002601200-2024-00059
• 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: 03/18/2024

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: 383736
• Device Lot Number: 3108270
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1