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

Model Number	21-7333-24
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the luer-lock broke off a smiths medical cadd administration set while it was in use with the pump.The issue occurred immediately and there was no clinical or patient injury.
Additional Manufacturer Narrative
Other, other text: one (1) pictures was received for evaluation.The sample luer is broken.No samples were received for evaluation.The following are relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities: pm-297 rev.113 ? ay, admin set, tsd volume.Pm-302 rev.101 - rra process monitoring: accuracy, leak and pull testing.Qp 67-7071 rev 114 ? deltec tpn/frra/stdrra.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp?s requirements and shm procedures: the bonding operation in all joins were reviewed in order to verify that the operation was correctly performed by the operator; no discrepancies were found.Verify that production personnel was performing visual inspection in order to detect delamination or any other workmanship defects; no discrepancies were found.The bin holding the filters was reviewed in order to verify that no damaged or broken filters were present; no discrepancies were detected.Training records were reviewed, operators are trained in the procedures reviewed; no discrepancies were found.Four (4) samples of the production floor were tested using a hydrostat vessel [cal.Id: 8.0088; due date: january 2021].No discrepancies were detected during leak testing; successfully passed.Production personnel performs a 100% visual inspection in order to verify that the joins of the filter following below criteria: minimum tube engagement is to edge of filter.Tube back out is not greater than 0.030?, using 0.030? pin.Delamination of 0.187? is acceptable, using td 0672 gage.Production performs a leak test to 4 units at shift start up, the end of every shift, the beginning of every job, the end of every job; a new lot of materials/components or equipment adjustment.Quality personnel takes a sample of fifteen (15) units every two (2) hours, prior to placing product in bag, in order to verify that tubes following the below criteria: for tube to tube bonds: bond engagement to be within 0.250" and 0.375".For tube to component bonds: verify tubing bonds are bottomed out or within 0.030" of component stops.Filter following below criteria: workmanship defect.Proper housing welds.Proper orientation.The tests are properly performed.The most probable root cause is the material was damaged after it left shm facility.No actions are required since it is unlikely that the material become damaged during the manufacturing process.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10365187
• Report Number: 3012307300-2020-07809
• Device Sequence Number: 2888329
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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 Expiration Date: 01/06/2025
• Device Model Number: 21-7333-24
• Device Catalogue Number: 21-7333-24
• Device Lot Number: 3915954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 10/03/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1