MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45052-TG

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

On (b)(6) 2020, a 5. 5 french double lumen picc line (cut to 38 cm length) was inserted on a (b)(6) year-old being treated with zosyn, tid, as an outpatient. The insertion was uneventful, easy to advance and had a great blood return to both ports. The patient arrived for an outpatient ct scan yesterday. The radiology team used the picc for iv contrast as is the standard for these pressure rated lines. Immediately on administration of contrast, the patient felt like his upper arm felt tight. Contrast administration was stopped. Pcxr obtained. The anesthesiologist examined the patient, reviewed the chest x-ray and was able to easily remove the line intact. There is an obvious visible fracture at the 5 cm mark.

• Brand Name: ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 10453773
• MDR Text Key: 206866836
• Report Number: 1036844-2020-00234
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ASK-45052-TG
• Device Lot Number: 23F19H0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial