MAUDE Adverse Event Report: CARDINAL HEALTHCARE ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when inserting a nasogastric tube, it was impossible to remove the guidewire.They had to take a clamp and pull very hard to remove it.By carrying out the control of the correct positioning with an air syringe, impossibility of pushing the air into the probe.So withdrawal of a probe and installation of a new one.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section b3: on 6/15/22 the event description was updated to include additional information received regarding the event.Section h6: medical device problem code 1504 has been added based on additional information received on 6/15/22.
Event or Problem Description
On 06/15/22 additional information was provided stating that after unscrewing the tip, the guide pulled manually, but, it did not come out as it felt that it was hooked.When the probe assembly with stylet was removed, the stylet appeared to have punctured the tip of the probe which was bent and split.The hydromer coating was reactivated before attempting removal with a little saline.No medical intervention was required other than a successful replacement of another probe that was a different model.
Additional Manufacturer Narrative
One sample from product code 8884721252e" was received for evaluation.The sample was visually inspected, and the reported condition was confirmed; the hub was disassembled from wire.Hub detachment can be caused by not activating the hydromer with enough fluid.According to the sample evaluation, the hydromer was activated and the stylet was withdrawn without a problem.The condition can be caused by not activating the hydromer making it difficult to remove the stylet from the feeding tube.The most likely root cause is indicative of a failure of the hydromer to activate during use making it difficult to remove the stylet from the feeding tube.The instructions for use (ifu) for the insertion of the feed tube and extraction of the stylet recommend using a syringe, to inject approximately 10 cc of water into the tube to activate the hydromer coating.Based on the analysis, the observed occurrence of harm (o) is (1, improbable) which is below the range of the expected occurrence of harm (o) (4, probable).A corrective/preventative action plan is not required since the reported condition has not been identified as manufacturing related.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no discrepancies were found according to the reported condition.A sample analysis was not possible since no photographs nor actual samples were provided for evaluation.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No physical samples nor photographs were received for evaluation therefore a possible root cause cannot be determined.The condition can be caused by not activating the hydromer making it difficult to remove the stylet from the feeding tube.The most likely root cause is indicative of a failure of the hydromer to activate during use making it difficult to remove the stylet from the feeding tube.The ifu instructions for the insertion of the feed tube and extraction of the stylet recommend using a syringe, to inject approximately 10 cc of water into the tube to activate the hydromer coating.A corrective/preventative action plan is not required since the reported condition has not been identified as manufacturing related.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTHCARE; 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 Key: 14548229
• Report Number: 9612030-2022-03267
• Device Sequence Number: 5158103
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2022

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
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2123616664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 05/30/2022; 05/30/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/15/2022; 08/18/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown