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

Catalog Number 383033

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Swelling (2091)

Event Date 05/28/2019

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 after the bd intima-ii¿ closed iv catheter system was used on a patient, the puncture site became red, swollen, and itchy.A cold compress was used to alleviate swelling, but two days later, the skin remained red and swollen, with discharge from the puncture site and high temperature readings.The needle site was wet compressed with a iodophor cotton ball, and the swollen skin was compressed with magnesium sulfate solution and a dexamethasone injection.Three days of anti-inflammatory treatment resulted in the redness and swelling subsiding.The following information was provided by the initial reporter, translated from chinese to english: "it was found puncture site red, swell and itchy, then removed the product.Cold compress was applied to the swelling area.On may 30, the skin was markedly reddened and swollen, the skin temperature was high, there were purulent secretions at the needle mouth.The purulent fluid was cleaned up, the needle site was wet compressed with iodophor cotton ball, the swollen skin was wet compressed with magnesium sulfate solution and dexamethasone injection.After three days of anti-inflammatory, dressing change and wet compress treatment, the patient's redness and swelling had subsided.".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8233371.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 after the bd intima-ii¿ closed iv catheter system was used on a patient, the puncture site became red, swollen, and itchy.A cold compress was used to alleviate swelling, but two days later, the skin remained red and swollen, with discharge from the puncture site and high temperature readings.The needle site was wet compressed with a lodophor cotton ball, and the swollen skin was compressed with magnesium sulfate solution and a dexamethasone injection.Three days of anti-inflammatory treatment resulted in the redness and swelling subsiding.The following information was provided by the initial reporter, translated from chinese to english: "it was found puncutre site red, swell and ithcy, then removed the product.Cold compress was applied to the swelling area.On may 30, the skin was markedly reddened and swollen, the skin temperature was high, there were purulent secretions at the needle mouth.The purulent fluid was cleaned up, the needle site was wet compressed with iodophor cotton ball, the swollen skin was wet compressed with magnesium sulfate solution and dexamethasone injection.After three days of anti-inflammatory, dressing change and wet compress treatment, the patient's redness and swelling had subsided.".

• 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
• MDR Report Key: 8722926
• MDR Text Key: 148799794
• Report Number: 3006948883-2019-00482
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/06/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8233371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention