MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; ANESTHESIA CIRCUIT-LF

Model Number	DYNJAAF6555
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by (b)(6) heart hospital that on (b)(6) 2020, "the white plastic connection piece is falling off during cases." the white plastic piece is a component of medline product code dynjaaf6555, anesthesia circuit- lf.The component was determined to be a busing for the breathing bag and 5 inch of tape x 3/4".The reporter is unable or unwilling to provide further information in regards to patient identifiers.Reporter states no serious injury, medical intervention, or follow-up care was needed or provided.No further information was provided.The sample is not available for return and evaluation and states it was thrown away, therefore a root cause will be difficult to determine.Due to the reported nature of the incident and in abundance of caution, this medwatch is being filed.Should additional relevant information become available a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, "the white plastic connection piece is falling off during cases.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: ANESTHESIA CIRCUIT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10694736
• Report Number: 1417592-2020-00117
• Device Sequence Number: 13734456
• Product Code: CAI
• UDI-Device Identifier: 10888277583573
• UDI-Public: 10888277583573
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2020

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 Model Number: DYNJAAF6555
• Device Catalogue Number: DYNJAAF6555
• Device Lot Number: 20GBN479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention