MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated medwatch number: mw5160945.
Event or Problem Description
It was reported initially by a representative of the health care facility "picc insertion (b)(6) 2024 at 12:27, 47cm right arm, basilic vein.Sterile chg gel dressing used.Rapid response team called 20:43 (patient found slumped in chair) dod (b)(6) 2024 at 04:26." it was received via medwatch "sterile chlorhexidine gluconate gel dressing.Start 12:15 end 12:27.Rapid response team called for condition change.Patient minimally responsive to painful stimulation.Patient presently slumped over in bedside recliner.Extremities essentially flaccid, possibly with recent posturing reported." additional information reports the cause of death was "unable to determine, the patient was dnr and after decline, family wished no more interventions.Subsequently received from the health care facility representative "suspect respiratory or possible brain bleed per notes.Unable to have ct secondary to acute condition; the provider suggested a brain bleed versus respiratory compromise.".
Additional Manufacturer Narrative
Qn#(b)(4).Associated medwatch number: mw5160945.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Clinical and medical affairs (cma) was consulted regarding this event.Per cma, the picc insertion does not appear to be associated with the patient death, which was 8 hours after the picc insertion.Nothing included from the customer demonstrates a correlation to the picc.Additionally, although the cause of death was not confirmed, the customer suggested that the death was related to a brain bleed.Based on the available information and without a sample returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported initially by a representative of the health care facility "picc insertion (b)(6) 2024 at 12:27, 47cm right arm, basilic vein.Sterile chg gel dressing used.Rapid response team called 20:43 (patient found slumped in chair) dod (b)(6) 24 at 04:26." it was received via medwatch "sterile chlorhexidine gluconate gel dressing.Start 12:15 end 12:27.Rapid response team called for condition change.Patient minimally responsive to painful stimulation.Patient presently slumped over in bedside recliner.Extremities essentially flaccid, possibly with recent posturing reported." additional information reports the cause of death was "unable to determine, the patient was dnr and after decline, family wished no more interventions.Subsequently received from the health care facility representative "suspect respiratory or possible brain bleed per notes.Unable to have ct secondary to acute condition; the provider suggested a brain bleed versus respiratory compromise.".

• Brand Name: ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG
• 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: 20507240
• Report Number: 9680794-2024-01042
• Device Sequence Number: 8590104
• Product Code: LJS
• UDI-Device Identifier: 10801902208610
• UDI-Public: (01)10801902208610(11)240416(17)251031(10)33F24B0527(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• 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): 09/27/2024

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: 10/31/2025
• Device Catalogue Number: DLX-45541-VPSC
• Device Lot Number: 33F24B0527
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2024
• 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.
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 103 KG