MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS LUERACTIV Y-SI; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2960-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation, 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 the customer tried to pass medical fluid through the needleless port connector (a nac) and the female luer-lock connector during the pre-use check, but would not.No patient injury or adverse affects.No additional information is available for this complaint.
Additional Manufacturer Narrative
Health impact and evaluation codes: updated a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and three pictures were received for evaluation.Visual and functional testing was performed.Visual inspection found the sample present an occlusion between the assembly of the tube and luer.Functional testing found the occlusion was detected between the assembly of the tube and luer.The failure mode reported is confirmed.The root cause of the reported issue was found to be manufacturing - excess solvent.Awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure gripper huber needle luer bonding assembly section 5.0 solvent bond tube to luer by quality engineer on (b)(6) 2022 this remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC GRIPPER PLUS LUERACTIV Y-SI
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15353168
• Report Number: 3012307300-2022-17579
• Device Sequence Number: 12267838
• Product Code: FPA
• UDI-Device Identifier: 10610586027680
• UDI-Public: 10610586027680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 21-2960-24
• Device Catalogue Number: 21-2960-24
• Device Lot Number: 4207415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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