MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC; INTRAVASCULAR CATHETER

Catalog Number 383718

Device Problem Packaging Problem (3007)

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

Event Date 12/20/2023

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 bd pegasus yel 24gax0.75in qsyte-capy nopvc had packaging damage.The following information was provided by the initial reporter, translated from chinese to english: used in the department for intravenous infusion, drug administration and taking blood samples, the packaging was found to be broken and not in compliance with aseptic operation at the time of use, and the hospital's storekeeper was contacted to replace it with a new product.

Manufacturer Narrative

Dhr/bhr review: the batch number of the complained product is 3170893, is 24g and product code is 383718, produced on 2023/07, with a total of (b)(4) pieces in this batch; inspection process inspection and delivery inspection report, the test results meet the product standards, no abnormality.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.The customer did not return any samples or photos ,cannot confirm the specific defect status.Take the retained samples 28pcs do the packaging appearance inspection, and no abnormalities were found.The inspection report is attached as attachment 1.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 customer did not return any samples or photos, can not confirm the specific defect of the product, 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 YEL 24GAX0.75IN QSYTE-CAPY NOPVC
• 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: 18530263
• MDR Text Key: 333485665
• Report Number: 3014704491-2024-00011
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 382903837182
• UDI-Public: (01)382903837182
• 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: 03/11/2024

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: 383718
• Device Lot Number: 3170893
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1