MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MINI TRANSFER DEVICE; SYRINGE, PISTON

Catalog Number	B6012
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a mini transfer device which was observed, during compounding, to have black particles within the filter.There was no patient involvement and unknown human harm reported.The customer reported that they were using the mini transfer device to dilute a penicillin vial within their cleanroom.The product was sealed; opening inside their laminar flow hood to use immediately during their compounding process.The customer also reported that the product was stored on a shelf with their iv supplies within their pharmacy space.
Additional Manufacturer Narrative
One photo was shared by customer, where the packaging of the affected device is showing, the product is sealed, however the contamination reported by customer is not observed.The complaint of particulate matter could not be confirmed by investigation.Since no used product sample was received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history review was reviewed and no non conformities were found that would have led the reported complaint.
Additional Manufacturer Narrative
The customer returned one photo for evaluation.The photo showed a black spot in the spike outside the fluid path.No additional damage or abnormally were observed.Fifty new unused samples were returned for evaluation on 10/4/2023.As inspected in one sample a a black embedded spot over the filter outside from the fluid path was found.This particulate size met product specification.Complaint of particulate matter can be confirmed.The probable cause of the embedded condition was due to a burn material during molding process.However, the size of the particles met visual package inspection criteria expectations.The device history review was performed and no non conformities were found that would have led the reported complaint.

• Brand Name: MINI TRANSFER DEVICE
• 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: 17755919
• Report Number: 9617594-2023-00717
• Device Sequence Number: 12454608
• Product Code: FMF
• UDI-Device Identifier: 00887709011021
• UDI-Public: (01)00887709011021(17)271101(10)11744785
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: B6012
• Device Lot Number: 11744785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (IV) PENICILLIN
• Patient Sex: Unknown