MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	KIT, POWER PAC II, VEN, PU, 2.6MM, UL 1/EA
Medical Device Problem Codes	Defective Component (2292); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical implantable ports|deltec power port-a-cath ii ports tube was defective.This was discovered during a operation to implant the device.The complaint states another device was implanted and no patient harm.Unknown if the defect was noticed before implantation and another kit was opened.
Additional Manufacturer Narrative
One power port-a-cath ii was returned for analysis.No discrepancies were found to the port tube or the catheter tip upon visual inspection.A port from manufacturing was taken and connected to the returned catheter for functional testing.The catheter was connected into the bottom of the tube with no difficulties.Relevant documents and the manufacturing process were both reviewed and deemed adequate.Visual inspection of personal and verifying that personal were putting the proper components in the tray were review; no discrepancies.No problems were observed and an audit of 32 units was done.Based on the evidence, the root cause is unknown as the complaint was not confirmed.

• Brand Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis, mn
• MDR Report Key: 9694318
• Report Number: 3012307300-2020-01218
• Device Sequence Number: 14164226
• Product Code: LJT
• UDI-Device Identifier: 10610586032691
• UDI-Public: 10610586032691
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2004
• Device Model Number: KIT, POWER PAC II, VEN, PU, 2.6MM, UL 1/EA
• Device Catalogue Number: 21-4454-24
• Device Lot Number: 3862391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1