MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383746

Device Problem Break (1069)

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

Event Date 01/19/2024

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 pnk 20gax1.16in prn-capy non-pvc tubing broke.The following information was provided by the initial reporter, translated from chinese to english: in the department of urology, when the indwelling needle was removed and the external tube was found to be broken, a green claim and a complaint reply letter were required.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3039620, is 20g and product code is 383746, produced on 2023/03, 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 defective sample,the product's luer connector and extension tube had separated, as shown in the attached photos 1 and 2.Observed the sample under microscope, found that the cross section of the extension tube was uneven and was suspected to be broken in the luer connector, as shown in the attached photo 3-5; cut open the luer connector and observe to confirm that the extension tube was broken and the fracture surface is uneven, as shown in attached photos 6 and 7.3.Take the retained samples of this batch to tets the extension tubing and luer adaptor separation force, 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.Cause analysis: (1) according to the samples returned by the customer, no damage was found on the surface of the extension tube.If there is damage to the extension tube, the product will leak during use; (2) according to the feedback from the sales representative, the product start use on january 17, 2024.Then was found the tube was broken by the companion on the morning of january 19, 2024, indicating that the product broke after two days of use.It is not sure whether the extension tube dragged by the patient.Conclusion: according to the samples returned by the customer, no abnormalities were found that would cause the extension tube to break.According to the feedback from the sales representative, the product was found to have broken after two days of use by the companion.It is not sure whether the extension tube was dragged by the patient, so can not confirm the cause of the extension tube broken.The factory will continue to pay attention to and monitor the trend of defect complaints.

Event Description

In the department of urology, when the indwelling needle was removed and the external tube was found to be broken, a green claim and a complaint reply letter were required.

• Brand Name: BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
• 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: 18620144
• MDR Text Key: 335082748
• Report Number: 3002601200-2024-00002
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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: 383746
• Device Lot Number: 3039620
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1