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

Model Number 21-2766-24

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the customer had difficulty passing medical fluid through the product.No patient injury was reported.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No problems or issues were identified during this device history record review.One sample was received, decontaminated; the sample was received in used condition with its open original package.During the functional testing, no occlusion was detected.The complaint was not confirmed.Root cause: based on the analysis conducted in the sample provided, the complaint was not confirmed.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16915943
• MDR Text Key: 315080414
• Report Number: 3012307300-2023-05607
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-2766-24
• Device Catalogue Number: 21-2766-24
• Device Lot Number: 4136064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1