MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7336-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that while in use, a patient that was receiving antibiotics on a portable infusion pump, experienced perforation on a smiths medical cadd administration set.The reporter indicated that the family discovered that medication was suddenly coming out of the backpack where the pump is located.In addition, the reporter indicated that half and hour before the incident, the patient had medication changed but not the administration kit.Subsequently, the medicine and sets were changed again and there was no consequence to the patient, but it was reported that the patient was completely neutropenic, and the kit was attached to her central nervous catheter, therefore the risk of contamination and infection was present.No adverse effects were reported.
Additional Manufacturer Narrative
Other, other text: h3: four pictures of the cadd administration set from part number 21-7336-24 were received for evaluation.In three of the pictures, it could be observed that the star tube was damaged.One picture showed the filter condition after the process sterilization, since could not was empty.One sample was returned and was visually inspected at a distance of 12? to 16? under normal conditions of illumination.A damage on the tube was detected just in a fold of the tube with the housing edge.A review of the manufacturing process for p/n 21-7324-24 l/n 4025958 was conducted by the quality engineer.The reported issue was able to be confirmed.The most probable cause of the issue is that the tube was coiled tightly during the packaging operation.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9267682
• Report Number: 3012307300-2019-06102
• Device Sequence Number: 11387375
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: Lay User/Patient
• Device Model Number: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1