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

Catalog Number 21-7394-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Event Description

It was reported that the device was in use with patient for infusion (ampicillin).The reporter stated the device was found to leak near the filter area.No adverse effects to patient reported.

Manufacturer Narrative

Device evaluation: eight (8) smiths medical cadd administration sets were returned for analysis.Seven (7) were unused with their original packaging and one (1) was used without its original packaging.Visual inspection showed delamination in at least one (1) join of the filter with the tube in all the received samples.Functional testing involved leak testing on all received samples and a leak was observed in the used sample at the air vent of the filter.No discrepancies were detected in the unused samples.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.The problem source could not be identified.Based on evidence and investigation, the complaint allegation was confirmed.

• 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: 8191543
• MDR Text Key: 131222849
• Report Number: 3012307300-2018-08988
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/30/2023
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 3633199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1