MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLES; 21-2960-24

Model Number	21-2960-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: customer/facility phone number: (b)(6).Company representative phone number: (b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that when a negative pressure was applied to the product, air got mixed in.The customer suspected that the air may have come from the y-site.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: device evaluation- a device photograph was provided; this showed air in the tubing area.One used sampled was returned for evaluation.The examination of the returned device showed no defects.A syringe was attached to the device and fluid was injected in effort to duplicate the reported issue.The device was found to allow flow with no air entering the tubing.The reported issue was not confirmed with the returned sample.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: 21-2960-24
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11169685
• Report Number: 3012307300-2021-00406
• Device Sequence Number: 2947317
• Product Code: FPA
• UDI-Device Identifier: 10610586027680
• UDI-Public: 10610586027680
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: No Information
• Device Model Number: 21-2960-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1