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

Model Number	21-2736-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012307300-2022-05994
• Device Sequence Number: 5656765
• Product Code: FPA
• UDI-Device Identifier: 10610586023224
• UDI-Public: 10610586023224
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 21-2736-24
• Device Catalogue Number: 21-2736-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown