MAUDE Adverse Event Report: COVIDIEN CATHETER SUCTION 14 FR 22IN STRAIGHT ST; CATHETER AND TIP, SUCTION

Model Number	31400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 that the device was opened to suction the patient's trach, and it was found that the tip of the catheter was detached in the package.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The sample was returned for evaluation.After performing the evaluation according to procedure, the reported condition was confirmed.The tip of the catheter was detached.The most likely root cause of this issue could be due to a blockage of the vents during manufacturing.A requisition was generated for the mold and maintenance was done to the injection mold.A production notification was performed to all personnel to ensure that they are aware of the condition reported by the customer.This complaint will be used for tracking and trending purposes.

• Brand Name: CATHETER SUCTION 14 FR 22IN STRAIGHT ST
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9853476
• Report Number: 9612030-2020-02436
• Device Sequence Number: 14106216
• Product Code: JOL
• UDI-Device Identifier: 10884527002153
• UDI-Public: 10884527002153
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 31400
• Device Catalogue Number: 31400
• Device Lot Number: 1925717164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1