MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Catalog Number	CDC-45552-VPS2
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: patient had a double lumen picc placed around aug 24th, at that time the patient was an inpatient receiving chemotherapy drugs (cytarabine) and antibiotics.The pt was discharged home with the picc on sept 6th and returned to the hospital on sept 24th, she had a ct with contrast of the abdomen and chest that was done on sept 25th, the picc was power injected@ 3cc per second with 100ml of contrast.The patient was sent back to the unit after the ct and it was discovered the following day that the white hub extension line/pigtail was "floppy" and looked like it had ballooned out and collapsed.The lumen was still flushing and not leaking, but the oncology clinician recommended not to use the white port, to use the pink port lumen for the remaining therapy (2 more doses of chemo were to be administered on (b)(6) and then line was to be discontinued on the 30th.The patient is fine and has not had any issues related to the picc and her therapy was not delayed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: patient had a double lumen picc placed around aug 24th, at that time the patient was an inpatient receiving chemotherapy drugs (cytarabine) and antibiotics.The pt was discharged home with the picc on sept 6th and returned to the hospital on sept 24th, she had a ct with contrast of the abdomen and chest that was done on sept 25th, the picc was power injected at 3cc per second with 100ml of contrast.The patient was sent back to the unit after the ct and it was discovered the following day that the white hub extension line/pigtail was "floppy" and looked like it had ballooned out and collapsed.The lumen was still flushing and not leaking, but the oncology clinician recommended not to use the white port, to use the pink port lumen for the remaining therapy (2 more doses of chemo were to be administered on sept 29th and then line was to be discontinued on the 30th.The patient is fine and has not had any issues related to the picc and her therapy was not delayed.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the returned sample.The customer provided two photos and returned one 2-l catheter for evaluation.Signs of use were observed on the catheter body and inside the extension lines.The catheter body appeared intentionally severed.Visual inspection revealed the proximal extension line had stretched/ballooned throughout the body.This damage is consistent with unintentional over pressurization of the extension line during use.The stretching on the proximal extension line measured 1-33mm via calibrated ruler from the hub.The catheter body length from the juncture hub to the severed end measured 15 1/4" via calibrated ruler, which was not within the specifications of 21 1/2"-22" per product drawing.This indicated that at least 6 1/4" of the catheter were cut and not returned.The proximal extension line outer diameter (od) in an area not stretched/ballooned measured 0.0949" via calibrated caliper, which was within the specifications of 0.093"-0.097" per product drawing.The extension line inner diameter (id) could not be accurately measured due to the damage.Functional inspection was performed per the product instructions for use which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the proximal extension line was flushed using a lab inventory 10ml syringe.Water exited out the catheter as expected.No leaks or blockages were observed.The instructions-for-use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Using catheters not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18000169
• Report Number: 9680794-2023-00794
• Device Sequence Number: 7537789
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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 Expiration Date: 11/30/2024
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 33F23D0597
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: CONTRAST, CYTARABINE; CONTRAST, CYTARABINE
• Patient Sex: Female