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

Catalog Number	MX2311L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at approximately 0810, the bedside nurse was readying the baby to be moved from his isolette to an open crib.In preparation, his blanket was changed to allow for swaddling and easy lifting from the bed/holding.During the change, while the nurse was being careful not to allow tension on the infants uvc, the three-way stopcock and iv tubing had become completely disconnected from the uvc.The iv tubing was infusing the baby's total parenteral nutrition (tpn) and intralipids.The healthcare professional immediately manually clamped the distal portion of the uvc and held it upright while simultaneously pausing the iv infusions.On further assessment, no evidence of any leakage of fluid was found.Two additional nurses were at the bedside with the bedside nurse (to assist with the bed change) at the time this occurred, so one assisted with clamping the line with a 2x2 gauze square and plastic hemostat while the other went to find help.Upon summoning two other nurses to the bedside the tbes were investigated for further potential leaking points.On further assessment (with bedside nurses all working together), no evidence of any leakage of fluid was found - neither on any of the bed linen (including the old blanket that had just been removed from under the patient), nor on the gloved hand of the bedside nurse who had noticed the disconnection.No damage or obvious deformity noted on either the uvc or the three-way stopcock that had come disconnected.Just prior to turning off the infusions, the fluids were observed to be just beginning to overflow from the distal portion of the stopcock.There was some air in approximately 2 inches of the distal length of the uvc catheter noted.There has been no report of patient injury or of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other text: g5: 510k number, d4: lot number, expiration date and h4: manufacture date are unknown, no information is available.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.
Additional Manufacturer Narrative
Other, other text: additional information is provided in h.2., h.3., and h.6.Product was not returned, and no photographic evidence was provided to aid in this investigation.As a result, a complaint investigation/product evaluation and problem confirmation cannot be performed.The exact cause could not be determined.A device history record (dhr) review cannot be performed because a lot number was not provided.If the product is returned the manufacturer will re-open the complaint for further device analysis.For all enquiries or follow-up questions related to the record, do not use regulatory.Located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: MEDEX STOPCOCKS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17552337
• Report Number: 3012307300-2023-08136
• Device Sequence Number: 17877366
• Product Code: FMG
• UDI-Device Identifier: 10351688508331
• UDI-Public: 10351688508331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX2311L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown