MAUDE Adverse Event Report: ST PAUL PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7061-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: (b)(6).
Event or Problem Description
Information was received indicating that during pre-use check a pump using a cadd extension set was unable to pass medical fluid through the product.No patient involvement.No additional information is available.
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that during pre-use check a pump using a cadd extension set was unable to pass medical fluid through the product.No patient involvement.No additional information is available.

• Brand Name: PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VA
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13568685
• Report Number: 3012307300-2022-03730
• Device Sequence Number: 12249819
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 21-7061-24
• Device Catalogue Number: 21-7061-24
• Device Lot Number: 4163589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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