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

Model Number	66040
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The syringe containing the extracted plastic thread like object was returned for evaluation but not the bag itself nor was the additional particulate returned.An unfilled companion sample not reported with any defect by the customer was also returned.No particulates were identified upon examination of the companion sample.The plastic thread like object was sent to a third party laboratory for composition evaluation via ftir.The results were inconclusive regarding the main particulate portion.Silicone oil was identified on the surface of the particulate.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
It was reported that a plastic thread like object and an additional particulate were found floating in a 100 ml 2 port eva bag containing the chemotherapy drug blincyto.The plastic thread like object was noted prior to adminstration to the patient.The thread like object was removed into a syringe by the customer and the chemo bag was subsequently administered to the patient.The additional particulate was described as another thread but no other information was provided.The customer stated the patient was not harmed.No additional information is available.
Additional Manufacturer Narrative
In additional conversations with the laboratory regarding the composition analysis, it was discovered that upon receipt at the laboratory the syringe contained multiple small round particulates.Given that the small round particulates were not reported by the customer, these are believed to have formed in the syringe during shipment to the laboratory.The laboratory confirmed they had initially extracted a small round particulate for analysis.This analysis corresponded to the inconclusive result.A photo supplied by the customer of the thread-like object was submitted to the laboratory and the laboratory recovered and analyzed the thread-like object.The thread-like object has a significant match to polycarbonate.Given the appearance of the particulate and that the injection site is the only component made of polycarbonate, it is likely that the particulate was due to a needle strike with the inner wall of the injection site during the filling of the bag.As the bag was discarded by the customer, the injection site was not available for review.Should additional relevant information become available, a supplemental report will be filed.

• Brand Name: SECURE
• Common Device Name: 100ML 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: 13384672
• Report Number: 1937141-2022-00001
• Device Sequence Number: 4624069
• Product Code: KPE
• UDI-Device Identifier: 00812496011541
• UDI-Public: 00812496011541
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K030888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2024
• Device Model Number: 66040
• Device Catalogue Number: 66040
• Device Lot Number: 66040-A7338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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