MAUDE Adverse Event Report: SMITHS MEDICAL PORT-A-CATH II IMPLANTED VENOUS ACCESS SYSTEM; CATHETER, PERCUTANEOUS, LONG TERM

Model Number 21-1500

Device Problem Fracture (1260)

Patient Problem Underdose (2542)

Event Date 03/26/2014

Event Type  Injury  

Event Description

From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug on (b)(6) 2013 and patient began trial (b)(6) 2013.According to reporter, patient was admitted to hospital (b)(6) 2014 for catheter breakage.The dose of arylsulfatase was not given to patient (b)(6) 2014 and dose was provided to patient via lumbar puncture on (b)(6) 2014.Implanted venous access system was replaced with different brand system on (b)(6) 2014 and patient was discharged from hospital.No permanent adverse effects to patient were reported.

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

• Brand Name: PORT-A-CATH II IMPLANTED VENOUS ACCESS SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, LONG TERM
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3883930
• MDR Text Key: 4591144
• Report Number: 2183502-2014-00395
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2014

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: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 21-1500
• Device Catalogue Number: 21-1500
• Device Lot Number: 2059573
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2014
• Distributor Facility Aware Date: 03/26/2014
• Device Age: 30 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 20