MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20130-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: potential lots found during investigation 13797183, mfr date 10/1/2023, exp date 10/1/2028; 13700069, mfr date 7/1/2023, exp date 7/1/2028; 13750333, mfr date 8/1/2023, exp date 8/1/2028; 13816107, mfr date 12/1/2023, exp date 11/1/2028; 13893676, mfr date 1/1/2024, exp date 2/1/2029; 13766464, mfr date 10/1/2023, exp date 9/1/2023; 13881912, mfr date 1/1/2024, exp date 1/1/2029; 13791548, mfr date 10/1/2023, exp date 10/1/2028.D9 - date returned to mfg - 17 may 2024.Investigation: received: four (4) used.List #unknown, spinning spiros¿, closed male luer; lot #unknown.One (1) used.List #206680490, extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock; lot #unknown.Pre-engineering evaluation: delay in receiving due to the customer combining all packaging, devices, and mating devices in the same package without proper labeling.Gcm has confirmed to separate spiros and device equally as there is no possible way to determine which spiros belongs to the corresponding lot numbers.Possible list numbers of the spiros according to the returned packaging could be: ch2000s-c, ch2000s, and 20130-01.Possible lot numbers could be: 13797183, 13700069, 13750333, 13816107, 13893676, 13766464, 13881912, and 13791548.The returned devices and packaging was split between multiple complaints.Multiple lot numbers were returned for list #206680490 mating device, possible lots for the mating devices: 13817543, 13726208, 13763281.Received four (4) used list #unknown spinning spiros and one (1) used extension set.All 4 spiros arrived activated and separated from the extension set.As received all spiros were observed to have damage on the threads of the post.The damage appeared to be a rollover and rollunder 180 degrees from each other, typical of bending of the mating device no spline or shear tab damage were noted on any of the spiros.No additional damage or anomalies were noted on the received items.Each spiros was functionally tested and dimensionally measures and met product performance specifications.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.The complaint of 'can easily remove the spiros or it comes disconnected itself' can be confirmed.The probable cause is due to unintentional bending forces at the bonding location.
Additional Manufacturer Narrative
E tab - additional initial reporter contact: (b)(6).A device evaluation is expected to be completed but has not yet been.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
An event that occurred on an unknown date involved a spinning spiros® closed male luer, red cap that experienced disconnection.The report stated that the spiros is attached to the filtered extension set.Customer hears the crack, confirming that the spiros should be bonded to the tubing.After hearing the crack when attaching the spiros to the tubing, the customer can easily remove the spiros or it comes disconnected itself.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, RED CAP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19590155
• Report Number: 9617594-2024-00804
• Device Sequence Number: 19709526
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)281001(10)13791548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: Other
• Device Catalogue Number: 20130-01
• Device Lot Number: 13791548
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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
• Patient Sex: Unknown