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

Model Number	21-2863-24
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer attempted to perform a priming during the pre-use check, but could not do it successfully due to resistance through the tubing.No patient injury.No additional information is available for this complaint.
Event or Problem Description
It was reported that the customer attempted to perform a priming during the pre-use check, but could not do it successfully due to resistance through the tubing.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
Other, other text: two (2) pictures were provided for evaluation.Picture (2) shows an occluded luer.One (1) unit was received for evaluation.Occlusion was detected between the assembly of the tube and luer.The failure mode reported is confirmed.The root cause was excess solvent applied during bonding assembly.Awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure by quality engineer on 02/mar/2022.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.

• Brand Name: DELTEC GRIPPER PLUS SAFETY HUBER NEEDLES
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13594643
• Report Number: 3012307300-2022-04130
• Device Sequence Number: 5059932
• Product Code: FPA
• UDI-Device Identifier: 10610586025679
• UDI-Public: 10610586025679
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 06/14/2026
• Device Model Number: 21-2863-24
• Device Catalogue Number: 21-2863-24
• Device Lot Number: 4146440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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