MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45541-RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "following dressing placement on picc line, patient began to complain of itching "all over".She also complained of strong saline taste with flush.The "itching" got worse and patient began to look acutely uncomfortable in the bed.Removed sterile draping and patient reported continuing to feel worse.Upon returning to the room, the patient was not responding to verbal cues and was now noted to be diaphoretic.At this time i called out for rrt to be notified.Pt appeared to be agitated and possible sz activity.Deviation to r and posturing, apenic and pulslessness> acls> rosc>.On arrival to pt room, pt was maintaining airway independently and was only responding to painful stimuli, while assessing for vitals patient went unresponsive and became apneic.At that point respiratory started to bag and with pulse check we began compressions and started the code with md, rns, and respiratory at bedside.After arrival to icu patient began to code again.Rosc achieved again and patient is now stabilized and in the care of the icu.Debriefed with all staff post code." the patient's current condition is reported as "deceased".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Although the sample was not returned, the complaint of catheter related allergic reaction is confirmed based upon the available information and assessment performed by clinical and medical affairs (cma).Based on the analysis of the customer report and autopsy data, cma has indicated that the patient experienced an anaphylactic reaction related to chlorhexidine.The patient appears to have suffered an anaphylactic reaction from a coated picc due to an unrecognized chlorhexidine allergy.Exposure of a sensitized individual to a chlorhexidine coated central vascular access device can lead to extreme allergic reactions due to the blood flow in the central circulation.The instructions for use (ifu) provided with this kit warns the user, "contraindications: the pressure injectable arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated: for patients with known hypersensitivity to chlorhexidine.Hypersensitivity potential: benefits of the use of this catheter should be weighed against any possible risk.Hypersensitivity reactions are a concern with antimicrobial catheters and can be serious and even life-threatening.Remove catheter immediately if catheter-related adverse reactions occur after catheter placement.".Therefore, the complaint of a catheter related allergic reaction is confirmed with a root cause of unintentional use error as the patient had an unknown but severe allergy to chlorhexidine.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
On (b)(6) 2024, a risk manager for the health care facility sent to teleflex the following notes from a nurse at the health care facility, "following dressing placement on picc line, patient began to complain of itching 'all over'.She also complained of strong saline taste with flush.The 'itching' got worse and patient began to look acutely uncomfortable in the bed.Removed sterile draping and patient reported continuing to feel worse.At this time, i went and found charge nurse as primary nurse was not at the desk.Upon returning to the room, the patient was not responding to verbal cues and was now noted to be diaphoretic.At this time, i called out for rrt to be notified.Pt appeared to be agitated and possible sz activity.Deviation to r and posturing, apenic and pulselessness> acls> rosc>." that same risk manager for the health care facility also sent to teleflex the following notes from the rrt referenced above, "on arrival to pt room, pt was maintaining airway independently and was only responding to painful stimuli, while assessing for vitals patient went unresponsive and became apneic.At that point respiratory started to bag and with pulse check we began compressions and started the code with md, rns, and respiratory at bedside.After arrival to icu patient began to code again.Rosc achieved again and patient is now stabilized and in the care of the icu.Debriefed with all staff post code." the patient's current condition is reported as "deceased".

• Brand Name: ARROW PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20570242
• Report Number: 9680794-2024-01061
• Device Sequence Number: 15318319
• Product Code: LJS
• UDI-Device Identifier: 10801902159974
• UDI-Public: (01)10801902159974(11)230427(17)240531(10)33F23D0860(21)
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: ASK-45541-RH
• Device Lot Number: 33F23D0860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown