MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383019

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Skin Inflammation (2443)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd intima-ii closed iv catheter system was used on the patient and a reaction occurred.The following information was provided by the initial reporter: after the patient was admitted on the (b)(6), the patient was given intravenous implantation of a closed intravenous indwelling needle at 12:00 noon to facilitate infusion.About 15 minutes after the implantation, the patient's arm puncture site appeared redness and swelling.The indwelling needle was removed according to the doctor's advice and the patient was observed.After about 20 minutes, the patient's symptoms improved.

Manufacturer Narrative

H6 investigation: a device history review was conducted for lot number 9347648.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.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.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 bd intima-ii¿ closed iv catheter system was used on the patient and a reaction occurred.The following information was provided by the initial reporter: after the patient was admitted on the 14th, the patient was given intravenous implantation of a closed intravenous indwelling needle at 12:00 noon to facilitate infusion.About 15 minutes after the implantation, the patient's arm puncture site appeared redness and swelling.The indwelling needle was removed according to the doctor's advice and the patient was observed.After about 20 minutes, the patient's symptoms improved.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10849437
• MDR Text Key: 216945501
• Report Number: 3006948883-2020-00758
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 383019
• Device Lot Number: 9347648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other