MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLU POWER IMPLANTABLE PORT; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number	21-3367-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Radiation Leak (1357)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the patient reported an approximately "3 inch 5fu" (5-fluorouracil) spill on their shirt due to the connector at the tip of the port coming loose.They stated the device was reconnected by the patient right away and no blood leaked from the line."atc was not called during the spill because it was just a little per the patient." the doctor was made aware of the event.The connector connection was checked, and the connector did easily disconnect from tip of port-a-cath catheter line.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
D10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Health impact and evaluation codes: updated.One device was received without its original packaging, in used condition and decontaminated.Visual inspection showed the unit arrived with traces of glue from the dressing on the distal end of the tube and base.No damage or dysfunctional conditions that could cause the reported failure were observed.No connector was provided, as described by the customer.The device was connected to a syringe filled with dyed water.The syringe was connected to the female luer connector without problems and water was introduced in the unit.The water passed through the whole device; no leaks or other connector problems were detected.The reported failure, connector problem, could not be confirmed.A root cause cannot be determined since the reported failure was not confirmed.A device history record (dhr) review showed there were no issues, nonconformance's reported during the manufacturing of the reported lot number.No corrective actions were taken as the complaint was not confirmed.

• Brand Name: DELTEC GRIPPER PLU POWER IMPLANTABLE PORT
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16497489
• Report Number: 3012307300-2023-02110
• Device Sequence Number: 6452188
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: 10610586033001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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 Model Number: 21-3367-24
• Device Catalogue Number: 21-3367-24
• Device Lot Number: 4248724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown