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

Model Number	21-7336-24
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during infusion of an oncology treatment via a smiths medical cadd administration set, a break in the line was observed.The break was noted to be located between the cassette and iv bag.It was reported that during a nursing check, the backpack which contained the pump, iv bag, and administration set was found wet.The infusion was then stopped, and a new administration set and iv bag was used.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Other, other text: h3: one cadd administration set from part number 21-7336-24 with an unknown lot number was received for evaluation.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.A kink in the extension tube was found.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.The tube sample was used for replicating the failure mode reported.The clip was activated in the tube damaged in order to verify; no damages could be replicated.The housing ffp was pushed against the tube to try to replicate the failure mode, no damages were created.A fixture for assembly process was used for replicated the damaged reported, a similar damaged in tube was created.The reported issue was able to be confirmed.The most probable root cause is that during assembly process the fixture slipped and created a damage in the tube.

• 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: 10476830
• Report Number: 3012307300-2020-08876
• Device Sequence Number: 2567540
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1