MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint is reported as: part of the peelaway sheath broke off in the patient's subcutaneous tissue upon removal.The piece of sheath has remained in the patient's arm since the insertion on 28-january.Removal of the sheath piece was to take place yesterday or today 18-february by cut down of the subcutaneous tissues at the insertion site.The piece was not actually in the vessel.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: part of the peel away sheath broke off in the patient's subcutaneous tissue upon removal.The piece of sheath has remained in the patient's arm since the insertion on (b)(6).Removal of the sheath piece was to take place yesterday or today on (b)(6) by cut down of the subcutaneous tissues at the insertion site.The piece was not actually in the vessel.The patient's condition is reported as fine.
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 a relevant finding was identified.A non-conformance was initiated for batch: 34c21j0107 to address the issue of a damaged sheath body.Despite this, it cannot be confirmed if the two issues are linked without the sample or an image to confirm the reported damage.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• 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: 13742509
• Report Number: 9680794-2022-00152
• Device Sequence Number: 4544738
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 02/17/2022

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?: Yes
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F21K0618
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: N/A.; N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male