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

Model Number	21-7024-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during use of this smiths medical cadd administration sets, tube leaking was noticed.It was reported that after removing the tubing, the customer noticed a puddle of product on the floor and this was caused by a leak from a cut (0.5/1 mm) on the tubing.No adverse effects were reported.
Event or Problem Description
Additional information was received indicating that there was no injury or clinical consequence observed.
Additional Manufacturer Narrative
Other, other text: 12 samples were returned for evaluation.Two of the twelve samples had a leak in the tube.The other ten samples had no faults found during testing.The initial complaint was able to be confirmed by analysis.The costumer reported: after removing the tubing, the user noticed a puddle of product on the floor.This was caused by a leak from a cut (0,5/1 mm) on the tubing." the most probable cause is that the product became damaged after it left the shm facility.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11273924
• Report Number: 3012307300-2021-00797
• Device Sequence Number: 3440259
• Product Code: FPA
• UDI-Device Identifier: 10610586019852
• UDI-Public: 10610586019852
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: Lay User/Patient
• Device Expiration Date: 06/17/2025
• Device Model Number: 21-7024-24
• Device Catalogue Number: 21-7024-24
• Device Lot Number: 4010276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 04/04/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/04/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1