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

Model Number	21-2735-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tube can not be filled.Port needle not passing / clogged.
Additional Manufacturer Narrative
Deivce evaluation a sample was received to perform an investigation.A visual inspection of the returned sample observed it to be received decontaminated in its original packaging opened in a plastic bag.A device history record (dhr) review was performed, and no issues were noted during manufacture.Functional testing was performed.The device was tested for occlusion by introducing water with a syringe.The occlusion test detected an occlusion between the assembly of the tube and luer.The failure mode reported was confirmed.The root cause was determined to be excess solvent applied in production.Awareness notification was given by the quality engineer to production personnel in order to explain the importance of following the procedure for bonding the tube to the luer.

• Brand Name: GRIPPER HUBER 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: 13652924
• Report Number: 3012307300-2022-04276
• Device Sequence Number: 2519964
• Product Code: FPA
• UDI-Device Identifier: 10610586015861
• UDI-Public: 10610586015861
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2026
• Device Model Number: 21-2735-24
• Device Catalogue Number: 21-2735-24
• Device Lot Number: 4091857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2021
• 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