MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX MICRO BORE EXTENSION SET W/ FILTER; FILTER, INFUSION LINE

Catalog Number FS116

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the infant patient's right upper arm picc running iv flolan was found detached, broken off from the cap.The med tubing cap was still attached to the picc hub, but the actual tubing had broken off from the cap.The tubing was coiled down into the brown, light-sensitive tubing bag about halfway, and the bag was soaked with flolan.The hub was immediately changed and flolan was strung up and restarted.The infant immediately became tachycardic to a heartrate in the 180s and was desatted down to the 170s, needing 100%.It was noted later that the infant's vitals had changed, with the heartrate dropping to the 130s and better oxygenation, being able to wean down to 70%.The cessation and restarting of flolan resulted in blood pressure decreases, with maps of 30, requiring the initiation of norepinephrine gtt needing a x4 increase, as well has acidotic gas of 7.18/80 needing increased support by decreasing the hertz to 4.It was presumed that the tubing likely broke off during an earlier round of care checks.The infant had been moved and his oscillator tubing had been moved to the right side where the picc was positioned.

Manufacturer Narrative

D9 and h6 - evaluation codes: updated.Device evaluation: no product sample nor photos have been received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number has been provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX MICRO BORE EXTENSION SET W/ FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18714999
• MDR Text Key: 335493952
• Report Number: 9616567-2024-00023
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention