MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS YEL 24GAX0.75IN QSYTE-CAP; INTRAVASCULAR CATHETER

Catalog Number 383718

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that bd pegasus yel 24gax0.75in qsyte-cap patent developed irritation and inflammation.The following information was provided by the initial reporter: when this product is used on a patient, the patient develops redness, swelling and pus; samples cannot be returned, photos are provided; green claims are required, and a complaint response letter and acceptance letter are required.2023-12-20 sales update information.Why did the patient have the indwelling needle inserted? where is the puncture site? what drugs were infused during this period? answer: the patient was hospitalized for treatment of herpes zoster and required intravenous infusion, so an indwelling needle was placed and the puncture site was on the wrist.During this period, methylcobalamin, lidocaine, etc.Were infused.See the attached picture for specific drugs.How long has the indwelling needle been used before ¿redness, swelling and pus discharge¿ appear? can you provide photos? answer: redness and swelling appeared after the indwelling needle was left in the left hand for two days, and redness and swelling appeared in the right hand after being left in the needle for one day.Does this patient have symptoms of systemic infection? answer: low fever, below 38 degrees, elevated high-sensitivity c-reactive protein will the "redness, swelling and pus" improve after the indwelling needle is removed? answer: it has improved.At the same time, the patient was given cephalosporins and antibiotics in the hospital.At present, the redness, swelling and pus have improved.

Manufacturer Narrative

1.Dhr review; the complaint lot 1355723 gauge is 20g, assembly at manual line at 2022/01, 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 attachment 383942-1355723 coc; 3.Customer returned 1 photograph, no actual sample returned.The photos show redness and swelling at the puncture site.But photos don't confirm failure mode.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.Customer returned 1 photograph, no actual sample returned.The photos show redness and swelling at the puncture site.But photos don't confirm failure mode.Customer feedback redness and swelling appeared after the indwelling needle was left in the left hand for two days, and redness and swelling appeared in the right hand after being left in the needle for one day,redness only appears in the same patient,same lot no same defect complaint, so cannot identify the root cause related with production.

Event Description

On 2023-12-20 sales update information, why did the patient have the indwelling needle inserted? where is the puncture site? what drugs were infused during this period? answer: the patient was hospitalized for treatment of herpes zoster and required intravenous infusion, so an indwelling needle was placed and the puncture site was on the wrist.During this period, methylcobalamin, lidocaine, etc.Were infused.See the attached picture for specific drugs.How long has the indwelling needle been used before ¿redness, swelling and pus discharge¿ appear? can you provide photos? answer: redness and swelling appeared after the indwelling needle was left in the left hand for two days, and redness and swelling appeared in the right hand after being left in the needle for one day.Does this patient have symptoms of systemic infection? answer: low fever, below 38 degrees, elevated high-sensitivity c-reactive protein will the "redness, swelling and pus" improve after the indwelling needle is removed? answer: it has improved.At the same time, the patient was given cephalosporins and antibiotics in the hospital.At present, the redness, swelling and pus have improved.

• Brand Name: BD PEGASUS YEL 24GAX0.75IN QSYTE-CAP
• 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: 18422067
• MDR Text Key: 331665178
• Report Number: 3014704491-2023-00859
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 383718
• Device Lot Number: 3136529
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention