MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. DOUBLE MICROCLAVE® SYRINGE TRANSFER SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number CH-33

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation, however, investigation is not yet complete.

Event Description

The event involved a double chemolock¿ port syringe transfer set in which the customer reported that it was initially thought that there was a micro bead or drop of fluid on the end of spiros when disconnecting; after infusing the unspecified drug on an unspecified date.However, it was later understood by the customer that the ¿drop¿ was in fact shards or pieces of plastic.The incident was noticed after infusion to the patient.There was no harm reported as a consequence of this event.

Manufacturer Narrative

A new ch-33 double clave syringe transfer set and new ch2000s-c spinning spiros were returned for investigation.Examination of the two devices did not reveal any particulate in the product assemblies or packaging.The two returned devices were connected and flushed with sterile water through a filter to capture any particulate in the fluid path.None was captured or observed.The complaint was unable to be replicated or confirmed.Without return of the affected samples a probable cause cannot be determined.A photograph was also received showing two small unidentified particles inside a polybag.The source of the particles cannot be determined from the photo.Lot history review was reviewed and no nonconformities were reviewed that may have contributed to the reported complaint.

Manufacturer Narrative

One new ch-33 double microclave syringe transfer set along with one new ch2000s-c spinning spiros were returned by your facility and investigated.A visual evaluation of the samples showed no visible defects or anomalies.The ch-33 set and ch2000s-c spinning spiros were examined, and no particulate was noted in the product assemblies or packaging.During testing, the spinning spiros was connected to the ch-33 double microclave and sterile water was flushed through the fluid path.The flushed fluid was filtered, and there was no evidence of particulate in the fluid paths of the ch2000s-c spinning spiros or the ch-33 set.The reported issue could not be confirmed on the sample returned.The customer requested that a representative from icu medical come on site to review an issue.The icu personnel met with staff of the user facility and was presented a bag of small shards or pieces of plastic.Staff mentioned that within the last two weeks, technicians have noticed what they thought was a small micro bead or droplet of fluid on the end of spiros connector when disconnecting from the ch-13 and/or ch-33.The icu personnel handled these pieces that were in the bag and confirmed that the small shards were solid in nature.Through investigation, it was found that these particles were returned with the complaint samples; however, these particles could not be located during the examination of the new samples returned.A photograph was returned showing two small unidentified particles inside a polybag.The source of the particles cannot be determined from the photo.

• Brand Name: DOUBLE MICROCLAVE® SYRINGE TRANSFER SET
• Type of Device: 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13709434
• MDR Text Key: 288626351
• Report Number: 9617594-2022-00048
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Model Number: CH-33
• Device Catalogue Number: CH-33
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/17/2022; 03/29/2022
• Supplement Dates FDA Received: 03/23/2022; 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CH2000-S; UNSPECIFIED MEDICATION, MFR UNK