MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Split (2537)

Patient Problems Swelling (2091); Reaction, Injection Site (2442)

Event Date 04/23/2015

Event Type  Injury  

Event Description

A picc was inserted on a (b)(6) female pt on (b)(6) 2014.The outpt was visited by a district nurse who reported a reaction - redness and swelling on the pt's arm at entry site and possible split lumen in the 5fr single silicon picc.It was noted that the area was red and swollen near the insertion site.No pain was reported.Fluid had gone into the tissue.The district nurse bled the arm on site.The treatment/intervention that was being given in the picc line is unk.Hospital staff removed the picc from the left arm on (b)(6) 2015.The picc was sent to pathology for infection control.A replacement picc was inserted on (b)(6) 2015 in the pt's right arm.No part of the device remained inside the pt.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned for investigation." based on this information, and with no attached pictures and no returned device, the investigation will be conducted based on the assumption that the lumen did in fact split as reported on the complaint form.A review of production records was conducted as part of the investigation.There were no nonconformances or irregularities in the production of the complaint set or component device according to production records.There is no evidence to suggest that the device was not manufactured to specification.The set is shipped with ifu which gives intended use, warnings, precautions, product recommendations, and instructions for placement, use and maintenance of the catheter.The ifu includes the warning, "extreme caution must be used in placement and monitoring of catheters." without return of the complaint device and based on the information available, we are inconclusive as to the root cause of this incident.We have notified the appropriate internal personnel and will continue to monitor for similar events.

Event Description

A picc was inserted on a (b)(6) female patient on (b)(6) 2014.The outpatient was visited by a district nurse who reported a reaction - redness and swelling on the patient's arm at entry site and possible split lumen in the 5fr single silicon picc.It was noted that the area was red and swollen near the insertion site.No pain was reported.Fluid had gone into the tissue.The district nurse bled the arm on site.The treatment/intervention that was being given in the picc line is unknown.Hospital staff removed the picc from the left arm on (b)(6)l 2015.The picc was sent to pathology for infection control.A replacement picc was inserted on (b)(6) 2015 in the patient's right arm.No part of the device remained inside the patient.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4745991
• MDR Text Key: 5884261
• Report Number: 1820334-2015-00293
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2017
• Device Model Number: N/A
• Device Catalogue Number: PICS-501-MPIS
• Device Lot Number: F4868153
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 74