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

Model Number	21-2965-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gripper tubing had leakage.No report of patient involvement.
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One device was received in used condition, decontaminated, without its original packaging and inside a plastic bag.Visual inspection showed a crack.Functional testing detected a leak, confirming the customer complaint.A probable root cause was due to wrong handling after the product left the manufacturing facilities since objects that could cause the type of cracks are not used during the product manufacturing.A device history record (dhr) review showed there were no issues, nonconformance's reported during the manufacturing of the reported lot number.No actions taken since the failure was not associated to manufacturing process.

• Brand Name: DELTEC GRIPPER PLUS SAFETY NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16817722
• Report Number: 3012307300-2023-04601
• Device Sequence Number: 7095532
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: 10610586027734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: Health Professional
• Device Model Number: 21-2965-24
• Device Catalogue Number: 21-2965-24
• Device Lot Number: 4332271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/11/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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 Sex: Unknown