MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; INTRAVASCULAR CATHETER

Catalog Number 383904

Device Problem Complete Blockage (1094)

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

Event Date 01/28/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus y 24ga x 0.75in ss prn npvc tubing was defective the following information was provided by the initial reporter: the patient was operated on (b)(6) 2024, and a cannula needle was left in place preoperatively, and it was noticed that the fluid was not dripping after a successful puncture, and a search was made for the cause of this, which was found to be an incompetent state at the connecting tubing.

Manufacturer Narrative

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

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 3261292, is 24g and product code is 383904,produced on 2023/10, 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 returned a sample.The product has been used and the single package has been torn.It cannot be confirmed whether the single package is the original package of the sample, as shown in the attached photo 1; observe the extension tube and confirm that the extension tube is in a flattened state, as shown in the attached photos 2-3; observe the sealing edge of the product's single package and find no abnormalities, as shown in attached photo 4.3.The history of customer complaints for the same batch of products has been reviewed, this complaint is the second complaint about product occluded, and the related complaint is (b)(4),but this product occluded was caused by the extension tube and cannot be confirmed to be related to the cause of complaint (b)(4); this complaint is the first complaint about the squashed of the extension tube.Cause analysis: (1) according to the analysis of samples returned by the customer, the extension tube was flattened under pressure.This product is packaged in the r245 packaging line.The extension tube of this product is npvc and the material is relatively hard.During the primary packaging, the product was not completely placed in place causing the extension tube to tilt up close to the sealing edge of the single package.When sealing the single package, the extension tube was flattened by sealing machine; (2) the secondary packaging operators also neglected to detect and remove defective products when inspecting the appearance of the products.Regarding to this complaint, already trained the primary packaging operators, secondary packaging operators of the r245 packaging line, to strengthen the correct placement and inspection of products.The training record is shown in the attachment.In summary, the root cause of this complaint is that the product was not completely placed in place during primary packaging, and the extension tube was tilted close to the sealing edge of the single package, causing it to be crushed by the sealing machine when sealing the single package; and the secondary packaging operators also neglected to detect and remove defective products when inspecting the appearance of the products, causing to flow into the market.Relevant operators have been promoted and trained to prevent such phenomena from occurring.The factory will continue to pay attention to this defect.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC
• 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: 18922996
• MDR Text Key: 337890280
• Report Number: 3002601200-2024-00088
• 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: 05/07/2024

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: Health Professional
• Device Catalogue Number: 383904
• Device Lot Number: 3261292
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1