MAUDE Adverse Event Report: COOPERSURGICAL, INC. NEO-FIT NEONATAL ENDOTRAC

Model Number	42-2540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported conditon.
Event or Problem Description
The metal grips are broken off, but not while in use, only while stored.Didn't notice it until we collected them for the recall.Neo-fit neonatal endotrac 42-2540 e-complaint-(b)(4).
Event or Problem Description
The metal grips are broken off, but not while in use, only while stored.Neo-fit neonatal endotrac 42-2540, e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation: review dhr.Inspect returned samples.Inspect stock product.Analysis and findings: complaint (b)(4).Distribution history: the neo-fit neonatal endotracheal product was manufactured at csi in april 2022.Manufacturing record review: dhr 319298 was reviewed, and no non-conformities were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Previous complaints were confirmed attributing the occurrence to potential mishandling while others could not be confirmed as units were not returned.See corrective action section for further details.Product receipt: the product was processed for a return via rma #339645 and returned 1/6/2023.Visual evaluation: a visual evaluation confirmed one tube of product had clips broken off.The other tubes of product were intact.Functional evaluation: a functional evaluation was executed with a check on the units that were intact by observing the ease of opening the clips.Further manipulation would end in breaking off the ends.Lot #319298 was confirmed to have been built with defective clips as well and the unshipped portion was discarded.Root cause: an investigation had determined the root cause is due to a defective component that may lend itself to breaking off.The defective component was provided by the supplier and not the result of a process step.Correction and/or corrective action: the complaint product was evaluated and confirmed to be the same issue that had been identified with available lots at the time.Coincidently, the lot checked previously is the same lot returned on this complaint.A review of the process during assembly confirms the clips are of stainless steel and put in place with the use of a press specifically designed to securely hold all relevant components in place.Further review of component 005-052 revealed a defect where the corners were noted to be out of specification under a non-routine inspection.A scar was issued to the vendor under ncmr-2022-09-003 which pulled all sk material to mr.Work orders (b)(4) in wip were placed on hold.A sampling from 2 lots were pulled (319298 & 311690) from fg august 2022 and confirmed to have the same weak spot on the clip ends.A regulatory hold was placed on this product and an hhe was generated.Recall #1216677-10/12/2022-001-r was issued.Final disposition of product on hold to be determined under capa 793 which was issued to complete the investigation and corrective actions.Note: lot #320280, placed on hold, was stripped of suspect clips and completed when updated clips arrived in november 2022.Train personnel: was the complaint confirmed? yes.

• Brand Name: NEO-FIT NEONATAL ENDOTRAC
• Common Device Name: NEO-FIT NEONATAL ENDOTRAC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16002427
• Report Number: 1216677-2022-00324
• Device Sequence Number: 20491968
• Product Code: JAY
• UDI-Device Identifier: 00888937016659
• UDI-Public: 888937016659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 42-2540
• Device Catalogue Number: 42-2540
• Device Lot Number: 319298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown