MAUDE Adverse Event Report: HALYARD HEALTH CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	42-9361
Medical Device Problem Codes	Partial Blockage (1065); Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is in the process of being returned for evaluation.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 24-jan-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).The device was not returned.
Event or Problem Description
A report was received stating the clinician unsuccessfully tried to flush the blocked nasogastric (ng) tube that had been in use for approximately 1-week.On removal of the ng tube it was noticed that the distal end of the tube snapped off at around the 60cm mark.An x-ray of the abdomen showed that the remaining portion of tube was in patient¿s stomach.The gastroenterology team was notified.The plan was to monitor the patient and wait for the distal end of the ng tube to pass through the gastrointestinal tract.No additional information was provided.
Additional Manufacturer Narrative
The root cause of the reported issue could not be conclusively determined.However; the cause for this incident seems to be a user related issue since as per the ifu, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.The complaint was confirmed by the sample analysis as described in the complaint.All information reasonably known as of 31-may-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
All information reasonably known as of 20-feb-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
One used ng tube and one style were returned.No product packaging was received.The product did not contain a lot number identification.During decontamination, a small amount of dried matter was flushed from the detached distal section of tubing.After decontamination, both sections of tubing could be flushed with no remaining obstruction.The skive in the bolus tip was free of buildup.The sample was examined under ambient light conditions.The tubing was ruptured at the 17cm depth marker.At that point, the tubing exhibits stretching, or "ballooning" and a complete rupture.The two ends were aligned to assess if any portion of the tube was missing.Based on the depth markers on both sections of the sample, it appeared that the full tube was present.Slight brown discoloration was observed on the detached distal section.No root cause was identified.All information reasonably known as of 13-apr-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7221195
• Report Number: 3009124963-2018-00004
• Device Sequence Number: 1483991
• Product Code: KNT
• UDI-Device Identifier: 20815149020659
• UDI-Public: 20815149020659
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2018

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: Other Health Care Professional
• Device Model Number: 42-9361
• Device Catalogue Number: 104608800
• Device Lot Number: 79652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/01/2018; 03/27/2018; 05/09/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/20/2018; 04/18/2018; 06/01/2018
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 88