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

Catalog Number 21-7383-24

Device Problem Partial Blockage (1065)

Patient Problems Dyspnea (1816); Unspecified Infection (1930); Inflammation (1932); Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Foreign source: (b)(6).

Event Description

Information was received indicating that after approximately four to six hours of total parenteral nutrition with a smiths medical cadd administration set with air-eliminating filter, an air bubble was observed.No adverse patient effects were reported.

Manufacturer Narrative

Additional information: adverse event or product problem,outcomes attributed to adverse event, type of reportable event, and patient codes.The following general additional information was provided by the cobo medical sas reporter regarding all ten reported complaints: (b)(6) mfr 3012307300-2019-05691, (b)(6) mfr 3012307300-2019-05692, (b)(6) mfr 3012307300-2019-05693, (b)(6) mfr 3012307300-2019-05694, (b)(6) mfr 3012307300-2019-05560, (b)(6) mfr 3012307300-2019-05543, (b)(6) mfr 3012307300-2019-05544, (b)(6) mfr 3012307300-2019-05545, (b)(6) mfr 3012307300-2019-05547, (b)(6) mfr 3012307300-2019-05548.The reporter stated "the shirt gets removed to adequately and appropriately clean the patient, when a shirt is removed it cannot be introduced again because the space is too small.In which it gets left out not due to patient safety since this kit has all the parts".They also stated a shirt was removed because "the patients had problems breathing as the bronchial pathway is very small." furthermore, the reporter indicated that the event has led to an increase in "tracheitis" for their patients.Additionally, the reporter noted it was necessary to complete a tube change out "various times".However, they could not confirm how many occurrences this intervention was required.Therefore, all ten related files will be considered as a serious injury due to the reported adverse patient effects and required intervention.The reporter also provided information below regarding these three related files: (b)(6) mfr 3012307300-2019-05694, (b)(6) mfr 3012307300-2019-05560, (b)(6) mfr 3012307300-2019-05543.It was stated that "suction had been direct already that the shirt is a medium to be able to conduct a good hygiene in the cannula, and after taking out the shirt it cannot be replaced given that it's so small and the material is very flexible so it folds when trying to reinsert it again and on occasions ruptures of the shirt have occurred.Also, infections in the patients have been increasing given that the direct manipulation that is done to the cannula due to not being able to re-insert the shirt again.".

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9204199
• MDR Text Key: 166597874
• Report Number: 3012307300-2019-05694
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027475
• UDI-Public: 10610586027475
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7383-24
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention