MAUDE Adverse Event Report: SHERIDAN SHER-I-SWIV/FO; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 5-15401

Device Problem Break (1069)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "a piece of the bronch adapter broke off and got stuck in the etco2 cuvette in the vent circuit".No patient injury reported.Patient condition reported to be fine.

Event Description

It was reported "a piece of the bronch adapter broke off and got stuck in the etco2 cuvette in the vent circuit".No patient injury reported.Patient condition reported to be fine.

Manufacturer Narrative

(b)(4).The customer returned one unit 5-15401 sher-i-swiv/fo for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed that the 15m part of the cobb connector was detached and not returned.The returned sample was sent to the manufacturing site for further investigation.Dimensional inspection could not be performed on the returned sample since the sample was damaged.However, production representative samples were tested.All 30 pieces of cobb connector tested by the manufacturing site were found to be within the specifications.No dimensional defects were observed with the production representative samples.Functional inspection could not be performed based on the condition of the returned sample.The returned sample was sent to the manufacturing site for further investigation.A pull test could not be performed on the returned sample since the 15m connector was already detached.However, a pull test was performed on current production representative samples.Fifteen samples were tested and all samples passed the pull test (withstand up to 8kg force applied without detaching).The ifu for this product states, "single use: do not reuse, reprocess or re-sterilize." "reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality." the reported complaint of "broken/cracked - double swivel connector" was confirmed based upon the sample received.Based on the testing performed by the manufacturing site, it appears that the returned sample most likely detached due to the application of high force.This failure appears to be isolated to (b)(4) complaints from one customer.Therefore, the root cause of this complaint is user error.An in-service request has been submitted.

• Brand Name: SHERIDAN SHER-I-SWIV/FO
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• MDR Report Key: 11046935
• MDR Text Key: 222687991
• Report Number: 3003898360-2020-01035
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5-15401
• Device Lot Number: 73L1900020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1