MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI; CATHETER,INTRAVASCULAR,THERAP

Catalog Number PR-05052-HP

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problems Irritation (1941); Pain (1994); Swelling (2091)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: due to pain and swelling at insertion site removed picc.Small split noted in catheter.Split was internal, approximately 1 cm from the skin exit site.Hospital could not establish any potential cause or origin.The picc was in for less than 24 hrs.The nursing staff in the ward called the vase team as soon as the patient complained of pain.This was due to magnesium leaking through the split causing vessel irritation.Picc removed.New picc inserted.

Manufacturer Narrative

(b)(4).The report that the catheter body ruptured was confirmed through examination of the returned sample.The catheter body was ruptured/split 78-83 mm from the distal end of the juncture hub.Microscopic examination of the ruptured area revealed that the catheter body was stretched and one edge was wavy.The catheter body likely stretched due to an increase amount of pressure caused by the buildup of biological material (found just below the split area) in the distal and proximal lumens.This eventually led to the catheter bursting and splitting.Since the appearance of the damaged site was consistent with the catheter rupturing due to pressure that exceeded the strength of the catheter body and the catheter was able to pass dimensional and functional testing, operational context caused or contributed to this event.No further action will be taken.

Event Description

The customer reports: due to pain and swelling at insertion site removed picc.Small split noted in catheter.Split was internal, approximately 1 cm from the skin exit site.Hospital could not establish any potential cause or origin.The picc was in for less than 24 hrs.The nursing staff in the ward called the vase team as soon as the patient complained of pain.This was due to magnesium leaking through the split causing vessel irritation.Picc removed.New picc inserted.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 7545454
• MDR Text Key: 109366827
• Report Number: 3003737899-2018-00052
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PR-05052-HP
• Device Lot Number: 14F18A0274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention