MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 100 ML 2 PORT EVA BAG

Model Number	66040
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated the events occurred during (b)(6) (146 units rejected) and (b)(6) (133 units rejected) of 2022 across two product types and 8 lot numbers; however, no specific event dates nor number of occurrences per lot were provided.The customer supplied two pictures of the "floaters" and the pictures were consistent with the customer's description.As the customer confirmed the additive port was used during the filling of the bags and no particulate was noted prior to filling, the floater could have been generated by inadvertent contact between the needle and wall of the additive port.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that floaters were found post-compounding, after injection of the bags.The customer further reported "we typically produce bupivacaine and ropivacaine dilutions in those bags, as well as narcotic combinations with them (fentanyl/bupivacaine or fentanyl/ropivacaine combinations, as well as the same with hydromorphone combinations).We also occasionally make midazolam dilutions in those bags as well.We use a peristaltic pump with a 16g bd needle to inject the diluent and drug into the bags.The 16g needle is used for a maximum of 5 punctures and the secure bag is being punctured only 2 times.We use the same compounding method for the alternative vendor's bags and we do not see this issue." the customer also stated "the 'floaters' were often little pieces of plastic of varying shapes and sizes ("circular", spiral, other shapes which could have more jagged edges).They were usually too small to see outside of a visual inspection box, and were the same colour as the eva bags themselves." as the floaters were noted at the filling pharmacy, there was no patient involvement.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 100 ML 2 PORT EVA BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, ; DR
• Manufacturer Contact: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 16499987
• Report Number: 1937141-2023-00005
• Device Sequence Number: 17702288
• Product Code: KPE
• UDI-Device Identifier: 00812496011541
• UDI-Public: 00812496011541
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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 Expiration Date: 02/22/2025
• Device Model Number: 66040
• Device Catalogue Number: 66040
• Device Lot Number: 66040-A7560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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