MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS; INTRAVASCULAR CATHETER

Catalog Number 383732

Device Problem Material Deformation (2976)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd pegasus tubing was defective/damaged on (b)(6) 2024, in the first ward of the obstetrics department, the nurse gave the patient an indwelling closed needle-proof anti-needle puncture type intravenous indwelling needle under aseptic operation, the puncture was smooth, the blood return was smooth, and the blockage was found to be not drip during the infusion of drugs, the inspection pipeline was not closed, and the transparent compress of the indwelling needle was uncovered and found that the hose under the y-shaped interface was flattened, resulting in the blockage liquid being unable to enter.Immediately reshape the indwelling needle and the infusion is unobstructed.No harm was caused to the patient.

Manufacturer Narrative

1.Dhr/bhr review: 1)the packaging batch number of the complained product is 3143884, is 22g and product code is 383732, assembled in suzhou plant, packaged and sterilized in tuas plant, singapore; the assembly batch number of this batch products is 3054501; assembled on 2023/03,this batch of products has (b)(4) pieces in total; 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 samples or photos,the defect status cannot be confirmed.3.Take this batch of retained samples for blocking test and flow 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 customer did not return any samples, the specific defect status cannot be confirmed, and the root cause of the complaint cannot be confirmed.The plant will continue to pay attention to and monitor the trend of the defect complaint.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS
• 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: 18888728
• MDR Text Key: 337776411
• Report Number: 3002601200-2024-00078
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 04/24/2024

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: 383732
• Device Lot Number: 3143884
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1