MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383912

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system backed out of the vein during use.The following information was provided by the initial reporter, translated from chinese: "(b)(6) 2022 after the 24g indwelling needle was successfully placed, the blood was not drawn smoothly, and the venous homepage did not drip.It needed to be pulled out again.According to the feedback, the puncture was normal, and the blood draw was abnormal after the puncture.There are also cases where the catheter sticks to the wall after puncture or the catheter is not in the vessel.".

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 2018792.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system backed out of the vein during use.The following information was provided by the initial reporter, translated from chinese: "2022-10-09 after the 24g indwelling needle was successfully placed, the blood was not drawn smoothly, and the venous homepage did not drip.It needed to be pulled out again.According to the feedback, the puncture was normal, and the blood draw was abnormal after the puncture.There are also cases where the catheter sticks to the wall after puncture or the catheter is not in the vessel.".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15762982
• MDR Text Key: 307303086
• Report Number: 3014704491-2022-00557
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903839124
• UDI-Public: (01)00382903839124
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383912
• Device Lot Number: 2018792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1