MAUDE Adverse Event Report: ST PAUL DELTEC; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	21-4071-24
Medical Device Problem Codes	Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical deltec port-a-cath ii implantable access system was noted to have inconsistent sizes than what was printed on the packaging.It was reported that the packaging had the chinese logo on it.Subsequently, the surgeon had to re-puncture the patient with the correct size.There were no reported adverse effects.
Additional Manufacturer Narrative
The device was not received at manufacturing site, investigation to be performed using photos supplied by the customer.Review of the photos shows a portal with a sliver (or whisker as it is sometimes referred to) of what is visually consistent with septum material extruding out from the portal's septum.This is consistent with the port having been accessed by a needle where as the needle is pushed into the port with excessive force which can barb the tip.Then upon removal of the needle this feature can remove a sliver of material.Also, this can happen should a portal be accessed with a standard needle rather than a non coring needle as is described in the products ifu under warnings and cautions, bullet #11.The customer reported condition was confirmed.

• Brand Name: DELTEC
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 9983073
• Report Number: 3012307300-2020-03345
• Device Sequence Number: 16973793
• Product Code: LJT
• UDI-Device Identifier: 10610586017841
• UDI-Public: 10610586017841
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: 21-4071-24
• Device Catalogue Number: 21-4071-24
• Device Lot Number: 3377723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention