MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; CATHETER

Catalog Number 383012

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

Patient Problem Necrosis (1971)

Event Date 12/13/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that intima-ii y 20gax1.16in prn/ec slm was used and caused an infection on the patient's foot.The following information was provided by the initial reporter: on (b)(6), when visiting the ward, the nurse found that the patient's left foot back was slightly red at the puncturing site, with an area of about 3cm*5cm, accompanied by a few small blisters.The indwelling needle was pulled out, and local magnesium sulfate wet compress was applied.Four hours later, the blister of the red and swollen part of the left dorsal foot of the patient increased, and the patient was given local disinfection of iodophor and then the fluid was extracted with fine needle.The next day, the above parts of the patient's skin were rusted, and the area of the rupture was about 0.5cm*3cm.On (b)(6), the patient was discharged from hospital.Local skin on the left dorsal foot was found to be ulcered and ruddy, with an area of about 4cm*5cm.The patient was covered with sterile gauze and instructed to disinfect at home with iodine volt.On (b)(6) 2021, the patient was admitted to hospital again after black necrosis occurred in the skin and soft tissue of the above parts.

Event Description

It was reported that intima-ii y 20gax1.16in prn/ec slm was used and caused an infection on the patient's foot.The following information was provided by the initial reporter: on (b)(6), when visiting the ward, the nurse found that the patient's left foot back was slightly red at the puncturing site, with an area of about 3cm*5cm, accompanied by a few small blisters.The indwelling needle was pulled out, and local magnesium sulfate wet compress was applied.Four hours later, the blister of the red and swollen part of the left dorsal foot of the patient increased, and the patient was given local disinfection of iodophor and then the fluid was extracted with fine needle.The next day, the above parts of the patient's skin were rusted, and the area of the rupture was about 0.5cm*3cm.On (b)(6), the patient was discharged from hospital.Local skin on the left dorsal foot was found to be ulcered and ruddy, with an area of about 4cm*5cm.The patient was covered with sterile gauze and instructed to disinfect at home with iodine volt.On (b)(6) 2021, the patient was admitted to hospital again after black necrosis occurred in the skin and soft tissue of the above parts.

Manufacturer Narrative

H6: investigation: a device history review was conducted for lot number 0019787.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.H3 other text: see h10.

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11408362
• MDR Text Key: 239103648
• Report Number: 3006948883-2021-00276
• 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: 03/08/2021

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?: No
• Device Operator: Other
• Device Expiration Date: 02/19/2023
• Device Catalogue Number: 383012
• Device Lot Number: 0019787
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention