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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN GASTRO INTESTINAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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CARDINAL HEALTH UNKNOWN GASTRO INTESTINAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number UNKNOWN GI
Device Problem Suction Problem (2170)
Patient Problems Aspiration/Inhalation (1725); Respiratory Failure (2484); Multiple Organ Failure (3261); Respiratory Insufficiency (4462)
Event Date 03/04/2022
Event Type  Death  
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Please note: per the customer, neither the product id nor lot number are available.As a result, the udi could not be determined.
 
Event Description
The customer reported that as part of a management on peritonitis, a gastric suction tube was placed on the patient to remove the gastric contents.The pvc salem probe was surgically installed and controlled by imaging.The wall suction system was functional and controlled by the nurses each time the patient passes.The non-efficiency of gastric emptying of the stomach led to inhalation of the patient.This inhalation led to the inhalation of gastric fluids by the patient.This inhalation led to his intubation with an endotracheal tube and a severe respiratory attack that threatened his life prognosis.This episode pushed the customer to question the reliability of the salem probe which was then changed.Gastric emptying was then done correctly after this change.The doctor and pharmacist reports that the patient born in (b)(6) has died.The event of the incident occurred on (b)(6) 2022.The pharmacist does not know the reference of the salem probe, the size of the probe and the probe concerned by this event has been discarded.The pharmacist specified that they organized a crex meeting and decided to change provider and write a care protocol.
 
Event Description
The customer reported that as part of a management on peritonitis, a gastric suction tube was placed on the patient to remove the gastric contents.The pvc salem probe was surgically installed and controlled by imaging.The wall suction system was functional and controlled by the nurses each time the patient passes.The non-efficiency of gastric emptying of the stomach led to inhalation of the patient.This inhalation led to the inhalation of gastric fluids by the patient.This inhalation led to his intubation with an endotracheal tube and a severe respiratory attack that threatened his life prognosis.This episode pushed the customer to question the reliability of the salem probe which was then changed.Gastric emptying was then done correctly after this change.The doctor and pharmacist reports that the patient born in 1965 has died.The event of the incident occurred on (b)(6) 2022.The pharmacist does not know the reference of the salem probe, the size of the probe and the probe concerned by this event has been discarded.The pharmacist specified that they organized a crex meeting and decided to change provider and write a care protocol.Per additional information received on 13jul2022, the sng was placed on (b)(6) 2022 in the icu.The device was monitored every 4 hours.On (b)(6) 2022, the patient experienced septic shock on colonic perforation peritonitis on colonic neoplasia.There was a left colectomy.On (b)(6) 2022, the patient was extubated.On (b)(6) 2022, the patient experienced acute respiratory distress and was re-intubated.Alveolointerstitial lesions were predominating in the upper lobes."etiological" workup indicated inhalation due to nts dysfunction (pnn alveolitis, negative bacteriology, rest of the workup negative).On (b)(6) 2022, the patient was extubated.On (b)(6) 2022, there was a recurrence of acute respiratory distress due to persistent inhalation of gastric fluid.On (b)(6) 2022, the patient experienced multivisceral failure leading to death.There was no model or batch number for the device available in the patient's file.Per additional information received on 01aug2022, the date of death was (b)(6) 2022."nts" stand for naso gastric tube."pnn" stands for neutrophiles polynuclears.
 
Manufacturer Narrative
The device history record could not be reviewed since no lot number was provided from the customer¿s complaint report, and no photo sample nor actual sample with a lot number was received.A sample analysis could not be performed since no photo samples nor actual sample device was received for evaluation.The root cause could not be determined without a sample to evaluate.The customer indicated the devices were discarded.Without the devices, a thorough investigation including visual and functional testing could not be performed.Although the lots are unknown for these events, device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for distribution.Based on the present information, and since no photo sample was provided and no actual sample was received, a possible root cause cannot be determined.The reported condition could not be confirmed nor related to a manufacturing process.Each lot of salem sump¿ tube with anti-reflux valve undergoes a visual, functional, and dimensional testing on an acceptance sampling plan.These tests are conducted in finished product assembly and the packaging process.The investigation was conducted with a multifunctional team, and the findings were that all processes and controls were found to be followed according to procedure, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.As control process and according to procedure for inspection standards for the salem sump catheters, visual, dimensional, and functional inspections are performed for each lot prior to product release.As part of the containment, a notification was made to the production personnel to heighten awareness of the condition reported by the customer.
 
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Brand Name
UNKNOWN GASTRO INTESTINAL
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
CARDINAL HEALTH
777 west street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key14859165
MDR Text Key295018535
Report Number9612030-2022-03301
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN GI
Device Catalogue NumberUNKNOWN GI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Death;
Patient SexMale
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