MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA; IMPLANTABLE PORT NEEDLE

Model Number 21-2736-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: the device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Event Description

It was reported that the patient experienced pain when flushing the gripper needle.The nurse reported leakage during flushing.The gripper needle was changed.No patient injury was reported.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA
• Type of Device: IMPLANTABLE PORT NEEDLE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14046174
• MDR Text Key: 288822399
• Report Number: 3012307300-2022-05994
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023224
• UDI-Public: 10610586023224
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K870866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2736-24
• Device Catalogue Number: 21-2736-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1