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

Catalog Number 383745

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus pnk 20ga x 1.16in prn non-pvc had foreign matter the following information was provided by the initial reporter: on (b)(6) 2024, in the (b)(6) surgery unit, a nurse was preparing to leave a preoperative intravenous access for a patient, and when she opened the package of the indwelling needle to check the quality of the product, she found that there were traces of the indwelling needle's hose path.Immediately discontinue use and report to the nurse manager to report a medical device adverse event to follow up on the quality.

Manufacturer Narrative

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

Event Description

No additional information provided.

• Brand Name: BD PEGASUS PNK 20GA X 1.16IN PRN 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: 18754658
• MDR Text Key: 336304397
• Report Number: 3002601200-2024-00049
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837458
• UDI-Public: (01)00382903837458
• 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: 04/09/2024

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: 383745
• Device Lot Number: 3227890
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1