MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.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 intima ii iv catheter prn adapter caused local fluid extravasation in the patient.The following information was provided by the initial reporter, translated from (b)(6) to english: "due to the need of left radial fracture internal fixation treatment, the nurse used closed venous indwelling needle for infution on (b)(6) 2020, after infusion, local fluid extravasation, skin was irritation, promptly removed to closed venous indwelling needle, it caused the waste liquid, and increases the patient secondary stinging pain".

Event Description

It was reported that the bd intima ii¿ iv catheter prn adapter caused local fluid extravasation in the patient.The following information was provided by the initial reporter, translated from chinese to english: "due to the need of left radial fracture internal fixation treatment, the nurse used closed venous indwelling needle for infusion on (b)(6) 2020, after infusion, local fluid extravasation, skin was irritation, promptly removed to closed venous indwelling needle, it caused the waste liquid, and increases the patient secondary stinging pain.".

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 8305823.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, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA II IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10860823
• MDR Text Key: 216893606
• Report Number: 3006948883-2020-00787
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8305823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR