MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS PNK 20GA X 1.16IN PRN; INTRAVASCULAR CATHETER

Catalog Number 383942

Device Problem Break (1069)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that 3 bd pegasus pnk 20ga x 1.16in prn catheters broke and leaked.The following information was provided by the initial reporter, translated from chinese to english: nurse practitioner reported a breakage at the clip wall of the indwelling needle extension tube during use causing fluid to flow out, number of units affected 3.

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

Nurse practitioner reported a breakage at the clip wall of the indwelling needle extension tube during use causing fluid to flow out, number of units affected (b)(4).

Manufacturer Narrative

1.Dhr/bhr review: (1)the batch number of the complained product is 1293375, is 20g and product code is 383942, produced on 2021/11, with a total of (b)(4) pieces in this batch; (2)inspection process and delivery test report, test results meet product standards, no abnormalities; (3)check the production record of the batch of products, no conformance, deviation or rework activities in the process of the batch of products; 2.The customer did not return sample and provided 3 photos of the sample.From the photos, it appeared that there were crack on the extension tube, but the specific damage status could not be confirmed, and it could not be confirmed whether it was damaged by the pinch clamp.3.Take the batch of retained sample for clamping test (64 times,and clamping 3 days), and 45psi system leak pressure test, 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.In summary,since the customer did not return sample, the specific defect status cannot be confirmed only from the photos provided by the customer,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.H3 other text : see narrative.

• Brand Name: BD PEGASUS PNK 20GA X 1.16IN PRN
• 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: 18858203
• MDR Text Key: 337307260
• Report Number: 3014704491-2024-00049
• 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: 04/29/2024

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: 383942
• Device Lot Number: 1293375
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1