MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS BL 22GA X 1.00IN PRN NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383904

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.D.4.Other lot number includes 3289309 with an expiration date of 2026-11-16.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2023-10-16.

Event Description

It was reported that the bd pegasus bl 22ga x 1.00in prn non-pvc had air bubbles/air in line.The following information was provided by the initial reporter translated from chinese to english: "it was found that there were bubbles in the extension tube of the product and the extension tube was frosted.".

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review: 1.The batch number of the complained product is 3261292 and 3289309, is 24g and product code is 383904, produced on oct,2023 and nov,2023, with a total of (b)(4).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 2pcs of samples, as shown in the attached photo 1.After observing the surface of the extension tube, confirmed that the surface of the extension tube is rough, it is due to the relatively high roughness of the extension tube caused by the extrusion process, it is not air bubbles, as shown in the attached photos 2-3.3.Take the retained sample of this batch to check the appearance of the extension tube, and find that the roughness of the extension tube is similar to the complained product, as shown in the attached photos 4 and 5.4.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.Cause analysis: 1.During the extrusion process, the roughness of the extension tube will fluctuate due to different melting parameters of the raw materials, resulting in a larger roughness of the extension tube of this batch of products.The technician will adjust the process parameters within the range according to the actual situation to control the roughness differences produced by raw materials.2.Compare the appearance of the extension tube of this batch of products with the current roughness acceptance standards, confirm that the products of this batch meet the current acceptance standards.Corrective action: 1.Based on market feedback, adjust the upper limit of the acceptance standard for the roughness of the extension tube, and control the roughness of the extension tube to be produced within the limit during the production process.2.Make the upper and lower limit samples of the extension tube roughness, and modify the sop document, write the sample photos into the standard operating procedure.In summary, this complaint is due to the fact that the roughness of the extension tube will fluctuate due to different melting parameters of the raw materials during the extrusion process, resulting in a larger roughness of the extension tube.In response to this problem, the factory readjusted the upper limit of the roughness acceptance standard and produced according to the new standard.The factory will continue to pay attention to and monitor the trend of defect complaints.

• Brand Name: BD PEGASUS BL 22GA X 1.00IN 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: 19111008
• MDR Text Key: 340908674
• Report Number: 3002601200-2024-00132
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1