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

Catalog Number 383912

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Extravasation (1842); Tissue Damage (2104)

Event Date 02/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: 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 during use there were burrs on needle which damaged blood vessels and caused extravasation of the drug with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to the hospital for treatment due to abdominal pain.During the puncturing on (b)(6) 2020 after the operation, it was found that there were burrs on the needle, which damaged the blood vessels and caused the extravasation of the drug solution.The operation was completed after the replacement of the new product.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9106501.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

Event Description

It was reported that during use there were burrs on needle which damaged blood vessels and caused extravasation of the drug with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital for treatment due to abdominal pain.During the puncturing on(b)(6)2020 after the operation, it was found that there were burrs on the needle, which damaged the blood vessels and caused the extravasation of the drug solution.The operation was completed after the replacement of the new product.

• 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: 9900900
• MDR Text Key: 187102585
• Report Number: 3006948883-2020-00105
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/04/2022
• Device Catalogue Number: 383912
• Device Lot Number: 9106501
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other