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

Model Number	8884711006E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter stated that this issue has happened more than once but was not able to quantify how many times.An 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 enfit connection on dobbhoffs is breaking off.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Physical samples were not received for evaluation, but four photos were provided.Using the digital images, the reported condition could not be confirmed.Physical samples are required to evaluate the reported condition.A root cause could not be determined as the reported issue couldn¿t not be confirmed.If samples are returned at a later date, the investigation will be updated accordingly.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.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.A sample without original packaging or lot number was received for evaluation.After performing a visual inspection per procedure, the connector was observed to be detached.The reported condition was confirmed.By reviewing the process, a root cause could not be determined.Changes are being made to support the validation of the solvent dispenser for the assembly of the y port.This change will improve the manufacturing process for a better handling of the solvent.This complaint will be used for 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: 8612745
• Report Number: 9612030-2019-02177
• Device Sequence Number: 16774965
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/30/2020

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: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 1809389864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 05/09/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 09/20/2019; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1