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

Model Number	8884711006E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
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 reports the y-shaped joint on the feed tube was leaking during irrigation and was occluded.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that the product was released meeting all quality standard requirements.A sample without the original package or lot number was received at the plant for the investigation.After performing a visual inspection, the reported condition by the customer was not confirmed.The product was not observed to be leaking or occluded but the connector was found to be detached.The customer was contacted and has since confirmed that they did observe the detachment but did not report this malfunction to us.The analysis concluded that the main root cause of the detached component was a workmanship issue.The condition is generated when an operator fails to complete an assembly or fails to follow the predetermined process steps to assure a complete assembly.The root cause for the leak and occlusion could not be determined as these reported issues could not be confirmed.Changes have been made to support the validation of the solvent dispenser for the assembly of the y port.This change is to improve the manufacturing process and have better control of the process assembly by implementing a new solvent dispenser for a better handling of the solvent.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: 8708945
• Report Number: 9612030-2019-02206
• Device Sequence Number: 13975837
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/02/2019

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: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/02/2019
• Patient Sequence Number: 1