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

Model Number	21-3468-24
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse was completing a blood draw and got air bubbles with flex of blood in syringe.The nurse then tried to tighten the connections and used multiple syringes to aspirate from the y- site connection of the huber needle tubing and still pulled back air bubbles instead of blood.Had to re- access patient with a different gripper needle huber set and the blood return was easily obtained.

• Brand Name: DELTEC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11682872
• Report Number: 3012307300-2021-03227
• Device Sequence Number: 2935599
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2021

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: Health Professional
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4027427
• 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: 03/17/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1