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

Model Number	21-2766-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, the customer noticed medical fluid would not pass through the product.No patient injury.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Pictures attached: three pictures were attached and reviewed.Result: picture one shows a gripper product.Pictures two and three show a mark in gripper tube.Sample received: one sample was received.Sample consist in gripper product in used conditions, decontaminated, without its original packaging and inside in a plastic bag.Visual inspection results: a mark was detected in the sample received.Functional test: sample was connected to a syringe and pass water trough fluid pathway to detect any malfunction.Results: water passed through fluid pathway without problems and no occlusions detected.Complaint is not confirmed by occlusion.No actions were taken due complaint was not confirmed.However, to reinforce the mark tube inspection condition detected a personnel notification was performed.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.

• Brand Name: DELTEC GRIPPER PLUS
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 14112252
• Report Number: 3012307300-2022-06385
• Device Sequence Number: 2134538
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• 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 Model Number: 21-2766-24
• Device Catalogue Number: 21-2766-24
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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