MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMISTRATION SET

Model Number	BX7007IDF120
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/02/2024, zyno received a report from a customer whom had purchased ax-80075 lot 2302002 and bx-70071-df lot 2309023 from infusystem, they stated they found hairs inside the tubing bags.The customer was going to be returning the remaining stock of these two lots to infusystem.Zyno medical has quarantined any of the remaining stock of these lots.Zyno medical, is attempting to obtain the actual samples to send in for an investigation.No patient was involved.
Additional Manufacturer Narrative
The affected bags had not been returned, they were requested to be return for further investigation.Testing results were reviewed.It was discovered that there were discrepancies in the test records.Ncr #2024-018 had been initiated to address the discrepancies.This mdr will be reopened and updated in the event the affected bags involved or additional information becomes available.

• Brand Name: ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 19355100
• Report Number: 3006575797-2024-00227
• Device Sequence Number: 20714973
• Product Code: FPA
• UDI-Device Identifier: 00814371020556
• UDI-Public: 00814371020556
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: Other
• Device Model Number: BX7007IDF120
• Device Catalogue Number: HS-008
• Device Lot Number: 2309023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown