MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383078

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Inflammation (2443)

Event Date 08/25/2019

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.

Event Description

It was reported that an serious injury / allergic reaction occurred with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter (chinese translation), "at 16:00 on (b)(6) 2019, it was red and pain for the patient on the indwelling needle placing site of the back of the right hand.After the indwelling needle was pulled out, it was not relieved obviously after the wet compress of magnesium sulfate.After using the 'deshishu ¿' applied to the affected area, it was better than before, but the skin temperature was still slightly higher.On (b)(6) 2019, the patient was admitted to the hospital again.It was found that the left forearm had an induration of about 2*10 cm, and the skin was red and the skin temperature was high.The patient complained of pain, chills, chills, and fever.The left forearm was slightly relieved by the cold pack of the ice pack.".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9023810.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 an serious injury / allergic reaction occurred with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter (chinese translation), "at 16:00 on (b)(6) 2019, it was red and pain for the paitient on the indwelling needle placing site of the back of the right hand.After the indwelling needle was pulled out, it was not relieved obviously after the wet compress of magnesium sulfate.After using the 'deshishu ¿' applied to the affected area, it was better than before, but the skin temperature was still slightly higher.On (b)(6) 2019, the patient was admitted to the hospital again.It was found that the left forearm had an induration of about 2*10 cm, and the skin was red and the skin temperature was high.The patient complained of pain, chills, chills, and fever.The left forearm was slightly relieved by the cold pack of the ice pack.".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9120269
• MDR Text Key: 164021974
• Report Number: 3006948883-2019-00806
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/26/2019

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: 02/22/2022
• Device Catalogue Number: 383078
• Device Lot Number: 9023810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention