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

Catalog Number 383033

Device Problem Improper Flow or Infusion (2954)

Patient Problem Pain (1994)

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 the prn on the bd intima-ii¿ closed iv catheter system swelled up during the infusion.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2023, at around 14:00 in the afternoon, in the department of infectious diseases, the patient was admitted to the hospital due to "new coronavirus infection, bacterial infection, lung cancer, and high blood pressure".During this period, he needed to use this product for infusion therapy.The responsible nurse took out the closed venous indwelling needle with complete outer packaging, and connected it to the infusion set according to the normal operation process.After exhausting the venipuncture, the venipuncture was successful.At around 9:10 am on (b)(6) 2023, the responsible nurse found that the medicine could not be infused when flushing the tube before the infusion according to the normal operation procedure, and the heparin cap of the closed intravenous indwelling needle was bulging.Immediately pull out the indwelling needle, press it for a while, and replace it with another closed venous indwelling needle of the same brand, specification and model, and the same batch.At the same time, the above-mentioned incident did not occur again after the second puncture was performed at the same time.The above-mentioned adverse events require re-puncture and increase the suffering of patients, so they are serious adverse events.The product manual does not specify the maximum indwelling time.After learning from the manufacturer, the indwelling needle has a 72-hour indwelling time, and the manual has been uploaded to the attachment.After asking the clinical nurse, i learned that the bulge of the heparin cap does not affect the airtightness of the indwelling needle, so i hereby explain.".

Event Description

It was reported that the prn on the bd intima-ii¿ closed iv catheter system swelled up during the infusion.The following information was provided by the initial reporter, translated from chinese: "on may 28, 2023, at around 14:00 in the afternoon, in the department of infectious diseases, the patient was admitted to the hospital due to "new coronavirus infection, bacterial infection, lung cancer, and high blood pressure".During this period, he needed to use this product for infusion therapy.The responsible nurse took out the closed venous indwelling needle with complete outer packaging, and connected it to the infusion set according to the normal operation process.After exhausting the venipuncture, the venipuncture was successful.At around 9:10 am on (b)(6), 2023, the responsible nurse found that the medicine could not be infused when flushing the tube before the infusion according to the normal operation procedure, and the heparin cap of the closed intravenous indwelling needle was bulging.Immediately pull out the indwelling needle, press it for a while, and replace it with another closed venous indwelling needle of the same brand, specification and model, and the same batch.At the same time, the above-mentioned incident did not occur again after the second puncture was performed at the same time.The above-mentioned adverse events require re-puncture and increase the suffering of patients, so they are serious adverse events.The product manual does not specify the maximum indwelling time.After learning from the manufacturer, the indwelling needle has a 72-hour indwelling time, and the manual has been uploaded to the attachment.After asking the clinical nurse, i learned that the bulge of the heparin cap does not affect the airtightness of the indwelling needle, so i hereby explain.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 3016098.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17553471
• MDR Text Key: 321236982
• Report Number: 3014704491-2023-00451
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383033
• Device Lot Number: 3016098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1