MAUDE Adverse Event Report: WESTMED LLC FLEX EXTENDER; FLEX EXTENDER, 5.2

Model Number	7-5132
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2028807-2024-00053 for the second report refer to 2028807-2024-00054 for the third report.It was reported, the flex connector separated from the breathing circuit, as it heated, in the middle of the case; they had to find the connection issue during the case and reattach it.There was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 0004292717 was reviewed and the product was produced according to product specifications.All information reasonably known as of 30 sep 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The device history record for lot: 0004292717 was reviewed and the product was produced according to product specifications.A representative sample was returned by the customer for evaluation, during set up, two of the connectors fell out; during testing the connection force was found to be below specification.In addition to testing, the drawings were inspected and it was determined the connector, on the returned product, did not have the retaining ring, which resulted in a poor connection force between the connectors and the flex tube.The reported event could be confirmed as reported; the root cause was traced to the manufacturing process.All information reasonably known as of 07 nov 2024, has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2028807-2024-00053 for the second report.Refer to 2028807-2024-00054 for the third report.It was reported, the flex connector separated from the breathing circuit, as it heated, in the middle of the case; they had to find the connection issue during the case and reattach it.There was no reported injury.

• Brand Name: FLEX EXTENDER
• Common Device Name: FLEX EXTENDER, 5.2
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20334026
• Report Number: 2028807-2024-00034
• Device Sequence Number: 18101934
• Product Code: CAI
• UDI-Device Identifier: 10709078008402
• UDI-Public: (01)10709078008402(10)0004292717(11)240723(17)290723
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Health Professional
• Device Model Number: 7-5132
• Device Lot Number: 0004292717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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