MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS SAFETY NEEDLES; NEEDLE, IMPLANTABLE PORT USE

Model Number	21-3260-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date and h4: manufacture date are unknown, no information has been provided to date.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 an rn was called to bedside due to patient's medial port tubing leaking.Tpn infusing through medial line at the time.The patient's line was clamped and tpn stopped.Rn tried to flush and heparinize line however fluid sprayed out of the side where tubing noted to be cracked.Patient's port was de-accessed.A slit in tubing noted where the tubing meets the bond.
Event or Problem Description
Additional information received: patient information has been updated with their respective fields.There was a hole noted in gripper micro tubing.Open fluid pathway increases risk for central line associated blood stream infections.
Additional Manufacturer Narrative
One device was received in used condition, without its original packaging, contaminated and inside plastic bag.The device was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.A cut was detected in the tubing that joins to the luer cavity.The device was connected to a syringe to inject water through the whole product until the catheter extreme as intended.Leaks were detected in the tubing that joins to the luer cavity confirming the complaint.The root cause was the tubbing was incorrectly handled during the use of the device since no leaks were reported in the process and no blades or sharp objects that could cause this type of cut are used during the manufacturing of the product.A device history record (dhr) review could not be performed as the lot number was unknown.No actions taken since the failure was not associated to manufacturing process.

• Brand Name: DELTEC GRIPPER PLUS SAFETY NEEDLES
• Common Device Name: NEEDLE, IMPLANTABLE PORT USE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16820025
• Report Number: 3012307300-2023-04620
• Device Sequence Number: 7125114
• Product Code: FPA
• UDI-Device Identifier: 10610586029837
• UDI-Public: 10610586029837
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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: Other
• Device Model Number: 21-3260-24
• Device Catalogue Number: 21-3260-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/20/2023
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/09/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 4 YR
• Patient Sex: Male