MAUDE Adverse Event Report: COVIDIEN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Lot Number PT00030482

Device Problem Decrease in Suction (1146)

Patient Problems Aspiration/Inhalation (1725); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Brand name is unknown at this time.Exact product code is unknown at this time.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 Description

The customer reported that the patient had an enfit nasogastric tube (ngt) placed for tube feedings while intubated and sedated in the intensive care unit (icu).The patient started to have coffee ground emesis so the ngt was placed to the wall suction.Only a limited amount came out and the patient vomited and aspirated.The patient required inter-venous (iv) antibiotics and a bronchoscopy.The customer stated there was no obvious signs that the tube was leaking or that an occlusion occurred.

Manufacturer Narrative

A device history record review could not be performed because a valid lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample was received at the manufacturing site for evaluation.The sample arrived without the original packaging or the lot number.Visual and functional evaluations were performed, and the reported condition could not be confirmed, the sample received met all specifications.A root cause could not be determined as the reported issue was not confirmed.Because a definitive root cause could not be determined, corrective action will be limited to manufacturing awareness 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.

• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8793284
• MDR Text Key: 151122174
• Report Number: 9612030-2019-02217
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PT00030482
• Date Manufacturer Received: 07/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 103