MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE DOSE VIAL ACCESS SPIKE; SYRINGE, PISTON

Catalog Number	CS-40
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
New devices were returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a single dose vial access spike.The reporter stated that upon opening up the device, brown particles were observed and 'you could see right through them' when unopened.There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
Received 150 new list #cs-40, single dose vial access spikes; lot #13490309.One of the returned samples was found to have a small brown particle in the package.However, the size of the particles met visual package inspection criteria expectations.The probable cause of the small particle (that met acceptance criteria) is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SINGLE DOSE VIAL ACCESS SPIKE
• Common Device Name: SYRINGE, PISTON
• 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: 20768051
• Report Number: 9617594-2024-01683
• Device Sequence Number: 9264511
• Product Code: FMF
• UDI-Device Identifier: 00887709042162
• UDI-Public: (01)00887709042162(17)271201(10)13490309
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K080989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Catalogue Number: CS-40
• Device Lot Number: 13490309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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