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

Catalog Number 383715

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd pegasus safety closed iv catheter system was used to infuse liquid into the patient, who left the hospital only to return "10 minutes" later.The end cap had fallen off as a result of q-syte damage, so the needle was removed and the patient was "disinfected and pressed".The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, the family members took the child away from the hospital after the completion of liquid injection and tube sealing.About 10 minutes later, the family members brought the child back to the infusion room.It was found that the heparin cap had fallen off, the child's indwelling needle was taken out, and the child was disinfected and pressed.".

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system was used to infuse liquid into the patient, who left the hospital only to return "10 minutes" later.The end cap had fallen off as a result of q-syte damage, so the needle was removed and the patient was "disinfected and pressed".The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2020, the family members took the child away from the hospital after the completion of liquid injection and tube sealing.About 10 minutes later, the family members brought the child back to the infusion room.It was found that the heparin cap had fallen off, the child's indwelling needle was taken out, and the child was disinfected and pressed.".

Manufacturer Narrative

Correction: after additional review, this report is a duplicate report of mfr # 3006948883-2020-00833.

• 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
• MDR Report Key: 10920389
• MDR Text Key: 218721027
• Report Number: 3006948883-2020-00857
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/14/2023
• Device Catalogue Number: 383715
• Device Lot Number: 0019695
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention