MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC; INTERVASCULAR CATHETER

Catalog Number 383083

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 05/26/2019

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 the intima-ii y 24gax0.75in prn ec slm npvc was involved in a serious injury in the form of an infection.The device was embedded within the patient for four days.The patient experienced redness, swelling, and pain.Magnesium sulfate was applied.The device was removed, and two days afterwards pus had formed in the site the device had been placed in.The following information was provided by the initial reporter: the patient was given a venous indwelling needle on (b)(6) 2019.On (b)(6) 2019, the patient's infusion site showed redness and pain.The nurse pulled out the indwelling needle and let it wet and hot.On (b)(6) 2019, the swelling and pain were worse than before.The patient apply with wet and hot compress with magnesium sulfate.On (b)(6) 2019, the doctor punctured the part with a syringe needle, squeezed out the yellow pus, and made bacterial culture.

Event Description

It was reported that the intima-ii y 24gax0.75in prn ec slm npvc was involved in a serious injury in the form of an infection.The device was embedded within the patient for four days.The patient experienced redness, swelling, and pain.Magnesium sulfate was applied.The device was removed, and two days afterwards pus had formed in the site the device had been placed in.The following information was provided by the initial reporter: the patient was given a venous indwelling needle on (b)(6) 2019.On (b)(6) 2019, the patient's infusion site showed redness and pain.The nurse pulled out the indwelling needle and let it wet and hot.On (b)(6) 2019, the swelling and pain were worse than before.The patient apply with wet and hot compress with magnesium sulfate.On (b)(6) 2019, the doctor punctured the part with a syringe needle, squeezed out the yellow pus, and made bacterial culture.

Manufacturer Narrative

Investigation: neither photo or sample was provided to aid in our quality engineer¿s investigation.With the lack of a sample, bd was unable to observe the failure mode.Master production records were reviewed for the lot number and no non-conformances were noted during the manufacturing of this lot.Our records indicate that the reviewed batch record passed all the in-process inspection.Only this complaint has been received for the reported defect and lot number.According to previous feedback, there are many factors that cause phlebitis.Common chemical phlebitis is mainly caused by drug infusion.Other possible related factors include; repeat infusion in a vein, causing pathological changes such as damage hyperplasia, hypertrophy and phlebitis.Puncture through the blood vessel was not found in time, resulting in leaking or small hematoma cause by local swelling caused by phlebitis.Disinfection during operation is not stick and causes infection some drugs may cause phlebitis.Phlebitis can be caused by excessively high drug concentrations, too low , too fast of a drip rate or a change in the plasma ph of a drug or an inappropriate ratio of a drug.The physical reasons of the patient itself.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9250947
• MDR Text Key: 178624592
• Report Number: 3006948883-2019-00878
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8043037
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other