MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNSPECIFIED BD INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unspecified bd infusion set was occluded the following information was received by the initial reporter with the following : rcc received a complaint via email.Email(s) attached.In regard to infusion sets and venting glass bottles while priming - "it would be helpful if the nurse could actually identify that the vent has been wet before attempting to infuse the drug.Perhaps some sort of color changing indicator?" 1.No adverse event occurred 2.No material number to provide, the comments were regarding the design of the standard secondary tubing set (not a particular batch/lot number) the situation i was describing was that a staff member would hang a secondary glass bottle infusion (i.E.Ofirmev) and wet the vent in the process; the second nurse would go in to hang the next dose of the drug but would be unable to tell that vet was wet by the previous user.So even if that second person went through the correct priming sequence for a glass bottle, they could still have slow or blocked flow; at this point you are wasting the drug and now you have to start over with new secondary tubing because you are unable to get the drug to flow.The suggestion was that it would be convenient if when the nurse walked in to hang the next dose (using the previously used secondary tubing) some sort of indicator (such as a color change indicator) would tell them that this vent on the tubing hanging was already wet and therefore cannot flow correctly before they spiked the new bottle with it.

• Brand Name: UNSPECIFIED BD INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18978332
• MDR Text Key: 338755739
• Report Number: 9616066-2024-00479
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1