MAUDE Adverse Event Report: SMITHS MEDICAL (DELTEC) POLYSULFONE POLYUETHANE CATHETER; PORT-A-CATH II POWER P. A. C. LOW PROFILE

Model Number 21-4473-24

Device Problems Misassembled (1398); Device Markings/Labelling Problem (2911)

Patient Problem No Code Available (3191)

Event Date 10/06/2017

Event Type  Injury  

Event Description

Origin of report: on friday, (b)(6) 2017, i ((b)(4), investigator - of safety, security and emergency management) received a report from (b)(6) (witness / operating room materials coordinator of a possible defective medical product that surgical services have removed from their inventory.Device info: the port-a-cath ii system provides an add'l option of power injecting contrast media for certain types of diagnostic imaging scans.Preliminary investigation: on friday, (b)(6) 2017, upon receiving the report pertaining to a medical device defect, i talked to (b)(6) (witness / operating room materials coordinator) to ensure that all defective port-a-cath device systems have been removed from inventory and are secured.On monday, (b)(6) 2017, at approx 1500-hours, (b)(6) (pt safety officer) put together a team of hospital personnel to look into this incident involving the defective device.The team not only consisted of (b)(6) and me, but also (b)(6) (witness/ director of materials mgmt), (b)(6) (witness/ of surgical services), (b)(6) (witness/manager surgical services), and (b)(6) (witness/interim cfo).Diagnosis for use: injecting contrast media for diagnostic imaging.

• Brand Name: POLYSULFONE POLYUETHANE CATHETER
• Type of Device: PORT-A-CATH II POWER P. A. C. LOW PROFILE
• Manufacturer (Section D): SMITHS MEDICAL (DELTEC); 1265 gray fox rd.; st. paul MN 55112
• MDR Report Key: 6993887
• MDR Text Key: 90933030
• Report Number: 6993887
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2017,10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: 21-4473-24
• Device Lot Number: 87X095, 87X100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2017
• Distributor Facility Aware Date: 10/06/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 77