MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER(TM) PORT A CATH NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2718-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient went to the nursing station to flush her port catheter.The needling itself went well, the port well in place and was able to prick well in the middle and felt resistance right away.However she checked if she was getting blood back, but this was not the case.Per request from patient to take out the needle, the clinician was unable to do so.The needle appeared to stuck within the patient's skin.Per general practitioner suggestion the patient was taken to the er to have device removed.Per the er staff the needle was removed and appeared to be bent.
Additional Manufacturer Narrative
It has been determined that complaint file (b)(4) with a manufacturing report number of 3012307300-2022-15093 was incorrectly assessed.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.

• Brand Name: DELTEC GRIPPER(TM) PORT A CATH NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 15195350
• Report Number: 3012307300-2022-15093
• Device Sequence Number: 17605184
• Product Code: FPA
• UDI-Device Identifier: 10610586015816
• UDI-Public: 10610586015816
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2025
• Device Model Number: 21-2718-24
• Device Catalogue Number: 21-2718-24
• Device Lot Number: 4037319
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown