MAUDE Adverse Event Report: SMITHS MEDICAL CLEO 90 INFUSION SET; SUBCUTANEOUS INFUSION SET

Model Number 21-7320

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Distributor reported on behalf of home-care user that during insertion of the listed subcutaneous infusion set, the metal needle of the insertion device separated and remained inside the plastic infusion site.The user removed the plastic infusion site and needle from his skin to find that he had successfully removed the needle, but the plastic cannula of the infusion site remained under his skin.User reported that he developed an infection at the site, but it "cleared up" leaving a hard lump in his skin.The user reported that he did not contact his healthcare practitioner about the issue; no treatment was attempted.No permanent adverse effects to pt reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

• Brand Name: CLEO 90 INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3959126
• MDR Text Key: 4624946
• Report Number: 2183502-2014-00322
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2016
• Device Model Number: 21-7320
• Device Catalogue Number: 217230
• Device Lot Number: 74X007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2014
• Device Age: 3 MO
• Event Location: Home
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1