MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2939-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was received for evaluation; the returned unit was received decontaminated without its original packaging.The unit was tested for occlusion by introducing water with a syringe.The unit sample was found occluded between the tube and luer.The failure mode reported is confirmed.As part of the standard process, production personnel perform a 100% visual inspection on the base for excess solvent and delamination.The root cause is excess solvent in the component bonding operation.No lot number was provided; therefore, a device history record (dhr) review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that, during the use of the product, the customer noticed the medical fluid was unable to be infused from the syringe to the needle; it could not be drawn.The customer checked the syringe and confirmed that the plunger moved without difficulty; therefore, it is suspected that there is an anomaly with the needle.No patient injury was reported.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA
• 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; 2-3-2 kamiochiai, chuoh-ku,; minneapolis, MN 55442
• MDR Report Key: 15397423
• Report Number: 3012307300-2022-18453
• Device Sequence Number: 5007311
• Product Code: FPA
• UDI-Device Identifier: 10610586016745
• UDI-Public: 10610586016745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870866
• 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
• Report Date (Section B): 09/10/2022

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: 21-2939-24
• Device Catalogue Number: 21-2939-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian