MAUDE Adverse Event Report: COVIDIEN N-C CONN TUBE 7MM X3.1M; TUBING, NONINVASIVE

Model Number	8888301713
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	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the blue connector has not been glued, it was detached in the unopened package.The device was not used.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on october 06, 2020.One unused sample with lot number 2027603364 was received for the investigation.A visual inspection was performed and the reported issue was confirmed.The detachment of the sure grip connector was observed.The tube did have solvent but the solvent was not uniform.A gemba walk was performed at the manufacturing area with the multifunctional team (quality, manufacturing, engineering).However, a specific root cause could not be found, the current process was running according to approved specifications.A potential root cause could be that at the time of manufacturing, the process required turning the tube to wet the entire diameter.The current process for solvent application is manual and uses a three-guide solvent dispenser which is specified for each tube size.The tube must be entered in the pin so that the solvent lubricates only the perimeter of the tube.Standard work instructions have been implemented for the new solvent dispenser.A corrective action is not applicable at this time as actions have already been implemented.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 7MM X3.1M
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12000625
• Report Number: 9612030-2021-02948
• Device Sequence Number: 19909850
• Product Code: GAZ
• UDI-Device Identifier: 10884527019700
• UDI-Public: 10884527019700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: No Information
• Device Model Number: 8888301713
• Device Catalogue Number: 8888301713
• Device Lot Number: 2027603364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1