MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. DELTEC® PORT-A-CATH®II; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 21-4474-24

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problems Extravasation (1842); Blood Loss (2597)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Lot number provided is not found in manufacturer database.Was unable to obtain expiration date or manufacture date.

Event Description

Information was received indicating that following implant procedure of a smiths medical deltec® port-a-cath®ii, the port became disconnected.The procedure was unable to be completed as the patient had noted blood loss and medication infused into the tissue.Subsequently, the port was explanted and replaced with a new one.There were no further adverse effects.

• Brand Name: DELTEC® PORT-A-CATH®II
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox rd; st. paul, MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7848369
• MDR Text Key: 119371733
• Report Number: 3012307300-2018-03546
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039966
• UDI-Public: 10610586039966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2018

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 Catalogue Number: 21-4474-24
• Device Lot Number: 87X218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention