MAUDE Adverse Event Report: BECTON DICKINSON BD NSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nsyte yel 24ga x 0.75in catheter was defective / damaged.The following information was provided by the initial reporter translated from french to english: (b)(6): 23-aug-2024 follow-up 1st attempt sent attached the e-mail in "attachment(s)" field below."1.Has there been any healthcare worker¿s exposure to blood or bodily fluids? ="no" 2.Have any other actions been taken? ="no" 3.Were there any negative consequences for the operator due to the leak or for patients due to the missed administration? ="no" 4.If you have retained a sample for investigation, please provide us with the pick-up address (full details ¿ please use the template below).="we only have specimens from the same batch, not the sample in question." name of establishment : "(b)(6).*to ensure smooth collection, we highly recommend leaving the package in an easily accessible location, such as main reception, hospital pharmacy or your goods-in/out department.5.The empty sample shipping box will be delivered to the same address.Please also provide us with the phone number of a person who can be contacted by the tnt carrier.="03 20 44 60 11 poste materiovigilance 32780.6.For your information, the plant accepts contaminated samples - except those contaminated with chemo products or hiv.For shipment/investigation please reserve samples of above accepted category only from the same batch and please confirm the same." (b)(6) : 21-aug-2024 received "bd rep's (yvan di tommaso ) event description confirmation": attached the screenshot in "attachment(s)" field below."hi, i just had customer : in this pir, we are talking about removal of catheter" thanks" ------------------------------------- after insertion of a catheter, caregivers notice swelling, leading to removal of the arm.On 29/07/2024 in a pediatric intensive care unit, 6 to 7 hours after insertion of a peripheral venous catheter, the caregivers noticed that the child's arm had swollen, requiring its removal.When the catheter was removed, the caregivers noticed that the catheter was pierced, probably as a result of the back-and-forth movement of the catheter on the chuck during insertion.This led to extravasation of paracetamol.Local alcohol dressings were applied to resolve these cutaneous symptoms.This is a recurring incident with this reference and is independent of the batch.Ansm declaration made when did the incident occur? during use.
Additional Manufacturer Narrative
Franklin lakes has been listed as the manufacturer.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.Current control there is an outgoing inspection and in-process inspection in place to check for cannula tip hooked or point damage and catheter tip damage.One representative sample was returned for investigation and no cannula tip damaged and catheter damaged was observed from the returned sample.Per verbatim, it was mentioned that the "when the catheter was removed, the caregivers noticed that the catheter was pierced, probably as a result of the back-and-forth movement of the catheter on the chuck during insertion.", hence the nonconformance could be introduced during production application.
Event or Problem Description
(b)(6): 23-aug-2024.Follow-up 1st attempt sent attached the e-mail in "attachment(s)" field below."1.Has there been any healthcare worker¿s exposure to blood or bodily fluids? ="no".2.Have any other actions been taken? ="no".3.Were there any negative consequences for the operator due to the leak or for patients due to the missed administration? ="no".4.If you have retained a sample for investigation, please provide us with the pick-up address (full details ¿ please use the template below).="we only have specimens from the same batch, not the sample in question.".Name of establishment : "(b)(6)".City: "(b)(6)".Collection link* : "(b)(6)" country : "france".Address 1 (street, number): "(b)(6)".Contact name: "(b)(6) / (b)(6)".Address 2 (building, floor, department) : telephone number : "(b)(6)".Postal code: "(b)(6)".Email address: "(b)(6)".*to ensure smooth collection, we highly recommend leaving the package in an easily accessible location, such as main reception, hospital pharmacy or your goods-in/out department.5.The empty sample shipping box will be delivered to the same address.Please also provide us with the phone number of a person who can be contacted by the (b)(4) carrier.="(b)(6)".6.For your information, the plant accepts contaminated samples - except those contaminated with chemo products or hiv.For shipment/investigation please reserve samples of above accepted category only from the same batch and please confirm the same.".(b)(6): 21-aug-2024.Received "bd rep's ((b)(6)) event description confirmation": attached the screenshot in "attachment(s)" field below."hi, i just had customer : in this pir, we are talking about removal of catheter" thanks".------------------------------------- after insertion of a catheter, caregivers notice swelling, leading to removal of the arm.On (b)(6) 2024 in a pediatric intensive care unit, 6 to 7 hours after insertion of a peripheral venous catheter, the caregivers noticed that the child's arm had swollen, requiring its removal.When the catheter was removed, the caregivers noticed that the catheter was pierced, probably as a result of the back-and-forth movement of the catheter on the chuck during insertion.This led to extravasation of paracetamol.Local alcohol dressings were applied to resolve these cutaneous symptoms.This is a recurring incident with this reference and is independent of the batch.Ansm declaration made when did the incident occur? during use.

• Brand Name: BD NSYTE YEL 24GA X 0.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20190058
• Report Number: 2243072-2024-00960
• Device Sequence Number: 20531328
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127(11)240207(17)290131(10)4038615
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381212
• Device Lot Number: 4038615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown