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

Model Number DYNJAAF6555

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

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 Description

It was reported, "the white plastic connection piece is falling off during cases.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: ANESTHESIA CIRCUIT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10694736
• MDR Text Key: 213696556
• Report Number: 1417592-2020-00117
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10888277583573
• UDI-Public: 10888277583573
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAAF6555
• Device Catalogue Number: DYNJAAF6555
• Device Lot Number: 20GBN479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention