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: when opening the package at the cardiothoracic surgery department, there was granular foreign matter in the xinma extension tube, which required a claim, a complaint reply letter, and a complaint acceptance letter.

Manufacturer Narrative

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

Manufacturer Narrative

A complaint history record(chr) review could not be performed as no batch/lot number was made available for this reported event.A device history review was unable to be performed since no lot/batch number was provided.A retain sample analysis review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause couldn't be determined due to unavailability of sample, and batch/lot number information.H3 other text : see narrative.

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: 18679448
• MDR Text Key: 335324370
• Report Number: 3006948883-2024-00018
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: 383745
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/23/2024
• 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