MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383725

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 bl 22ga x 0.75in prn non-pvc had foreign matter.The following information was provided by the initial reporter: november 20, 10:50, received the radiology department report: closed anti-needle-stick injury type intravenous indwelling needle package with water droplets, breaking the ring of the consumables of the closed sterile environment, can not be used to the patient for fear of causing infections and other adverse consequences, and then immediately reported to the department of medical equipment and materials and replacement of the product was not used for the patient, did not cause any adverse effects.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3079648, is 22g and product code is 383725, 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, cannot confirm the specific defect status; 2.Take the retained samples (b)(4) do the inspection, and no abnormalities were found.The inspection report is attached as attachment 1; 3.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, based on the customer complaint information, there are water droplets inside the packaging.It is suspected that the damage to the single packaging caused the water droplets to enter the packaging.Due to the customer did not return any samples or photos, can not confirm the packaging damage status.Therefore, the root cause of the complaint cannot be confirmed, and the factory will continue to monitor and monitor the trend of the defect complaint.

Event Description

No additional information received.

• Brand Name: BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18489005
• MDR Text Key: 333011922
• Report Number: 3014704491-2023-00899
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837250
• UDI-Public: (01)00382903837250
• 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: 03/08/2024

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: 383725
• Device Lot Number: 3079648
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1