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

Catalog Number 383083

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported that bd intima-ii y 24gax0.75in prn ec slm npvc developed irritation/inflamamation.The following information was provided by the initial reporter: the patient was given an intravenous indwelling needle to puncture the patient's vein for indwelling infusion on (b)(6) 2023 due to diabetes mellitus condition, the next day the patient complained of localized redness and swelling, and continued to use it due to its fair appearance, until the patient complained of pain on the back of the hand at around 15:20 pm on (b)(6), the nurse immediately looked at it and found that there was a pus spot at the puncture site.The indwelling needle was immediately discontinued and a surgeon's consultation was requested to disinfect with iodophor and elevate the affected limb.The consultant found that the patient still had thrombus, and then transferred to a provincial hospital for treatment, and called back in about half a month to say that the localized pus spot had improved.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr review; the complaint lot 3234435 gauge is 24g, assembly at auto line2 at 2023-09, lot quantity is (b)(4) ea, the product is with the expiry date; review the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it.Review the assembly record, there no nonconformities, deviations or rework activities for this lot product; 2.Sterilize rvw exempt rationale ; checked all complaint lot of the batch record, raw material processes no changes.The sterilization process is normal, the bi sterility test passed, and the eo residue test passed, the product met the requirement of bi sterility test before released, see the 383083-3234435 coc; 3.Not able to confirm the indicated failure mode since was not received defective unit sample or photos.4.According to preview ma feedback, there are many factors that cause the skin redness and wellness.Common is mainly caused by drug infusion (including configuration solution).Other possible related factors include: ¿puncture through the blood vessels was not found in time, resulting in leakage or small hematoma caused by local swelling.¿disinfection during operation is not strict and causes infection.¿some drugs may cause skin redness and wellness.¿the physical reasons of the patient itself.5.No related defect complaint from same lot, cannot identify it related with production.Conclusion no found any abnormal for the assembly & sterilization process and production line & the production environment initial bacterial contamination monitor no found any abnormal.Not able to confirm the indicated failure mode since was not received defective unit sample or photos,same lot no same defect complaint, so cannot identify the root cause related with production.H3 other text : see narrative.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18415862
• MDR Text Key: 331577200
• Report Number: 3014704491-2023-00856
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383083
• Device Lot Number: 3234435
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization