MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383019

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

Patient Problem Extravasation (1842)

Event Date 08/29/2020

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 extravasation occurred while using intima-ii y 22gax1.00in prn/ec slm.The following information was provided by the initial reporter: the patient was admitted to our department on august 25 due to adolescent bleeding and severe hemorrhagic anemia.Transfusion and fluid infusion would be performed after hospitalization.Intravenous indwelling needle 22 (bd: intima-ii) was performed in the right forearm, and 0.9% sodium chloride + omeprazole 60mg will be injected in the days ahead.100ml alanyl glutamine + 250ml compound amino acid; 250 ml 0.9% sodium chloride + sucrose iron 5 ml, etc., on aug.27 17:00 input ammonia acyl group c after 100 ml, of infusion fluid leakage, pulled out the needle, the surrounding skin slightly swelling, redness, minor aches and pains, (b)(6) 9:30 to see patients, found right forearm swelling, pain, the right upper limb b to exceed check, found that the center of the right forearm venous showed low solid inside.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8141365.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.

Event Description

It was reported that extravasation occurred while using intima-ii y 22gax1.00in prn/ec slm.The following information was provided by the initial reporter: the patient was admitted to our department on august 25 due to adolescent bleeding and severe hemorrhagic anemia.Transfusion and fluid infusion would be performed after hospitalization.Intravenous indwelling needle 22 (bd: intima-ii) was performed in the right forearm, and 0.9% sodium chloride + omeprazole 60mg will be injected in the days ahead.100ml alanyl glutamine + 250ml compound amino acid; 250 ml 0.9% sodium chloride + sucrose iron 5 ml, etc., on aug.27 17:00 input ammonia acyl group c after 100 ml, of infusion fluid leakage, pulled out the needle, the surrounding skin slightly swelling, redness, minor aches and pains, august 29th 9:30 to see patients, found right forearm swelling, pain, the right upper limb b to exceed check, found that the center of the right forearm venous showed low solid inside.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10687627
• MDR Text Key: 212475541
• Report Number: 3006948883-2020-00565
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/03/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8141365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other