MAUDE Adverse Event Report: COVIDIEN POLYUR F T 6.5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461438E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
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 rn was going to place an ng.When the rn opened the packaging of the ng tube, the rn noticed that the tube was split in half.When the rn was inspecting the tube, the rn also noticed that on the side of the tube there was an opening.The rn repackaged the tube to give to supervisor and notified the supervisor of the event.That specific ng tube was never inserted into the patient.
Additional Manufacturer Narrative
H3 evaluation summary: a review of the device history record (dhr) was reviewed, and no discrepancy was found according to the reported failure.One decontaminated sample with the reported lot number was received.After performing a visual inspection based on procedure, it can be observed that the tubing was trapped in the seal.The product being trapped in the seal could cause occlusion or shearing of the tube.The reported condition was confirmed.There is currently a formal investigation being conducted through a corrective and preventative action (capa) which was opened to address this type of failure mode though a more robust investigation.

• Brand Name: POLYUR F T 6.5FRX36IN W ENFIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12051948
• Report Number: 9612030-2021-02963
• Device Sequence Number: 17249267
• Product Code: PIF
• UDI-Device Identifier: 10884521547148
• UDI-Public: 10884521547148
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/27/2021

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: 461438E
• Device Catalogue Number: 461438E
• Device Lot Number: 2002840764
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1