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

Model Number	21-3251-24
Medical Device Problem Codes	Connection Problem (2900); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deltec gripper micro needles gripper failed to latch back into the safety latch.The operator pulled up the safety arm and heard a click sound.The needle was left exposed.This product problem was observed prior to patient use.The product was not used on the patient.

• Brand Name: DELTEC GRIPPER MICRO NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10811622
• Report Number: 3012307300-2020-11269
• Device Sequence Number: 3526217
• Product Code: FPA
• UDI-Device Identifier: 10610586029745
• UDI-Public: 10610586029745
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• 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
• Report Date (Section B): 11/09/2020

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: 21-3251-24
• Device Catalogue Number: 21-3251-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1