MAUDE Adverse Event Report: COVIDIEN 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771810E

Device Problems Suction Problem (2170); Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

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.

Event Description

The customer reported that the patient's ng was not suctioning.It is currently working, but per the nurse, not as it should.Also, when changing the multiport device, the connection site broke.

Manufacturer Narrative

A device history record (dhr) review could not be performed because a lot number was not provided.The lot number of the package returned (lot 2007737864s) is from a subassembly that is used to make the finished product but does not correspond to the final product therefore the dhr could not be reviewed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A picture was provided for evaluation.However, the root cause of the reported condition stated by the customer could not be determined from the picture provided.One decontaminated sample with subassembly lot 2007737864s was received for evaluation.The returned device was functionally tested according to the specifications.The reported condition of the ng not suctioning was not confirmed; the sample passed the testing, and no issues were found.The dimensions of the device in the specific section where the port is assembled with the salem tube was also checked.The results were determined to be within specification as well as the length of the port.The reported issue of a broken connector was not confirmed as the connector was not found to be broken or with any failures.A review through the manufacturing process was conducted.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported conditions.Since the issues reported by the customer were not confirmed, a corrective action is not applicable at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

Manufacturer Narrative

Section b1 has been updated to indicate that both a product problem and adverse event occurred.Section b2 was updated to indicate an important medical event occurred.Section b5 was updated to include additional details provided by the customer.Section d10 has been updated to indicate that the device has been received for evaluation.Section h1 has been updated to reflect serious injury.Section h3 has been updated to show that the evaluation has not yet begun.Section h6 was updated to 3191 appropriate term/code not available, please note: the patient required sicu admission, intubation, and antibiotics.Section h6 has been further updated to indicate that the device has been received but both the result and the conclusion of the investigation are pending at this time.An investigation is currently underway, the results will be shared upon completion.

Event Description

The customer reported that the patient's ng was not suctioning.It is currently working, but per the nurse, not as it should.Also, when changing the multiport device, the connection site broke.Additional information provided by the customer stated that there was an injury associated with this event.The patient required sicu admission, intubation, and antibiotics.The nurse further stated that she felt that the suctioning was not as strong as it should have been, it was lackluster or mediocre.

• Brand Name: 18FR SALEM W/ GIENTRI PORT WIT
• 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: 10645397
• MDR Text Key: 210383460
• Report Number: 9612030-2020-02650
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other