MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2965-24
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient noticed a leakage of chemotherapy product (5-fluorouracil) with skin contamination.It would be a crack at the injection site of the y-connector.In addition, a venous return and blockage of the implantable chamber by probable coagulation were reported.The same incident was noted by a nurse when the gripper was replaced.
Additional Manufacturer Narrative
Operator of device is unknown.No information has been provided to date.The lot 4218799 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufactured.The complaint returned unit was visually inspected at 12 inches to 16 inches under normal conditions of illumination.One sample was received for evaluation; the returned sample was received decontaminated and without its original package inside a plastic bag.The root cause is that the product became damaged after left the shm facility, because the material undergoes 100% occlusion test, and the components are required to be in good condition to be able to perform the test.No actions taken up today since the failure is not associated to manufacturing process.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 15607102
• Report Number: 3012307300-2022-24069
• Device Sequence Number: 2314697
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: 10610586027734
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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
• Device Model Number: 21-2965-24
• Device Catalogue Number: 21-2965-24
• Device Lot Number: 4218799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• 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: 09/19/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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