MAUDE Adverse Event Report: SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CH2000-PC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received two new spiros closed male luer, purple cap with list #ch2000-pc and lot #4988506, one used spiros closed male luer, purple cap with list #ch2000-pc and lot #4988506, one used 72" (183 cm) appx 0.89 ml, smallbore extension set with microclave clear, 0.2 micron filter, clamp, luer lock with list #mc33904 and lot #5462805, and one used 10ml syringe with unknown list number and lot #1133339.The used mc33904 extension set with a non-spinning spiros bonded at the distal end was pressure leak tested and found to leak at the poppet/o-ring interface.Subsequent disassembly revealed a malformed o-ring that resulted in leakage.The probable cause of the leakage is a malformed o-ring.The two new ch2000-pc spiros were leak tested and both met product performance expectations without leakage.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a spiros closed male luer with purple cap.It was reported that microbore tubing with spiros caps applied to all connection sites was used to infuse chemotherapy (cyclophosphamide) on a syringe pump and programmed to infuse over an hour.After infusion and flush was completed by the nurse it was reported that she noticed a wet spot on the chux pad under the patient.The nurse noticed dripping from the connection site where the chemo had been infusing.She reported it was coming from where the spiros connects to the clave of the bifuse which attaches to the patient¿s central line.It was reported that most, if not all the chemo leaked into the patient¿s bed.The bone marrow team and pharmacist were notified, and it was decided to administer half of the original dose to the patient.Therefore, the set up was changed out and the patient was re-dosed without any further issues.There was patient involvement however no report of human harm.

• Brand Name: SPIROS® CLOSED MALE LUER, PURPLE CAP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12720682
• Report Number: 9617594-2021-00291
• Device Sequence Number: 17254458
• Product Code: FPA
• UDI-Device Identifier: 00840619023812
• UDI-Public: (01)00840619023812(17)250901(10)4988506
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Model Number: CH2000-PC
• Device Catalogue Number: CH2000-PC
• Device Lot Number: 4988506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFUSE, MFR UNK; CYCLOPHOSPHAMIDE, MFR UNK; MICROBORE TUBING, MFR UNK