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

Catalog Number 383012

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

Patient Problems Fatigue (1849); Discomfort (2330); Numbness (2415)

Event Date 11/16/2020

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.(b)(4).

Event Description

It was reported that after the intima-ii y 20gax1.16in prn/ec slm was used to replace intraoperative and postoperative fluid, the patient experienced "numbness, fatigue and discomfort" in their left hand ring finger.The arm was elevated, massaged, and a hot compress was applied, but the symptoms have not yet improved.The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient was admitted to the hospital on (b)(6) 2020 due to "knife stabbing pain and bleeding in the inner left thigh for 2 hours", and was admitted to the hospital for emergency "left inner thigh skin laceration, wound extension, vascular nerve, muscle exploration and anastomosis + plaster,"external fixation", the indwelling needle is placed into the dorsal side of the left hand before the operation, so that intraoperative and postoperative fluid replacement and medication can be used.After pulling out the indwelling needle on (b)(6), the patient felt numbness, fatigue and discomfort in the left hand ring finger, and no other abnormalities.Elevate the affected limb, apply hot compress and massage locally, and continue to observe the condition.As of the reporting date, the above symptoms have not improved.".

Manufacturer Narrative

H6 investigation: a device history review was conducted for lot number 9347639.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 after the intima-ii y 20gax1.16in prn/ec slm was used to replace intraoperative and postoperative fluid, the patient experienced "numbness, fatigue and discomfort" in their left hand ring finger.The arm was elevated, massaged, and a hot compress was applied, but the symptoms have not yet improved.The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted to the hospital on (b)(6) 2020 due to "knife stabbing pain and bleeding in the inner left thigh for 2 hours", and was admitted to the hospital for emergency "left inner thigh skin laceration, wound extension, vascular nerve, muscle exploration and anastomosis + plaster,"external fixation", the indwelling needle is placed into the dorsal side of the left hand before the operation, so that intraoperative and postoperative fluid replacement and medication can be used.After pulling out the indwelling needle on november 13, the patient felt numbness, fatigue and discomfort in the left hand ring finger, and no other abnormalities.Elevate the affected limb, apply hot compress and massage locally, and continue to observe the condition.As of the reporting date, the above symptoms have not improved.".

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11033533
• MDR Text Key: 223375155
• Report Number: 3006948883-2020-01009
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: 383012
• Device Lot Number: 9347639
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention