MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
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 during use, the dobhoff ng tube cracked under the enfit port connection.This occurred in the icu while the product was inserted in a patient.There was no injury to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample was received at the manufacturing site for the investigation.The sample arrived without the original packaging or lot number.Upon a visual evaluation of the sample, the reported issue could not be confirmed.A root cause could not be determined as the reported issue was not observed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DOBBHOFF 10FR;43IN W/STYLET EN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9006438
• Report Number: 9612030-2019-02263
• Device Sequence Number: 19458689
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 1809389864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 12/05/2019
• Patient Sequence Number: 1