MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. MINI SPIKE DISP PIN; SET, I.V. FLUID TRANSFER

Device Problems Patient Device Interaction Problem (4001); Air/Gas in Device (4062)

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

Event Description

Spontaneous.Pt's spouse reports when using the new spikes with the diluent (substituted due to shortages) they reported a bubble larger than a pea in the cassette.Spouse wasn't able to break it up.Spouse stated they have worked with cnss (b)(6).In the past and still has his number.Advised spouse to contact cnss and rph will also contact cnss (b)(6) for additional assistance in removing the bubble from cassette.In the meantime, spouse will mix another cassette and wait to see if they can salvage the cassette in question.Advised spouse that premixed cassettes with remodulin sterile diluent are good for 14 days at room temp.Pharmacy sent request to cnss (b)(6), and cnss supervisors for pt follow up.Per cnss, (b)(6): "i assisted with removing air from the cassette.I'm doubtful that this was a product issue it appeared that the patient didn't remove the air from the cassette." cassette and spike lot numbers unknown.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette is available to be returned for investigation? no; did we [mfr] replace the cassette? no; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 14137881
• MDR Text Key: 289735347
• Report Number: MW5109142
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female