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

Model Number	20-9438
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	01/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 06-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.(b)(4).
Event or Problem Description
It was reported that a patient's feeding tube appeared to be in place from abdominal films taken periodically.On (b)(6) 2018 the patient reportedly began to have nausea and vomiting; therefore, tube feeds were put on hold.The kub showed the tube tip peri-pyloric but the proximal tube could not be visualized.Trickle feeds were started (b)(6) 2018.On (b)(6) 2018, a new corflo feeding tube was placed, with notes in the record suggesting the patient may have pulled out the first tube.Later imaging showed two tips in the patient, and a 28.5 cm piece of feeding tube was later removed from the patient¿s stomach.Additional information was received on 19-mar-2018 that states the piece of feeding tube was removed endoscopically.Carbonated beverage and warm water flushes and a clog zapper, was used to resolve clogged tube issues.No additional information was provided.
Additional Manufacturer Narrative
Halyard health received one partial, nasogastric (ng) tube sample.No product packaging was received.The product did not contain a lot number identification.During decontamination, it was not possible to flush fluid through the tubing.The distal portion of the ng tube was also received.The section measures approximately 29.5 cm in length.At the point of separation, the tubing "ballooned" or stretched and ruptured.The bolus tip was attached to the tubing.After decontamination, additional attempts were made to flush the tube.The occlusion remained and could not be dislodged.The tube pinched at various intervals to try to determine the location of the occlusion.At approximately 4cm from the distal tip, the tubing felt firm and could not be depressed.This was determined to be the proximal-most point for the occlusion.The bolus tip was examined under magnification.Dried brown matter was observed inside the opening of the bolus tip.The evaluation of the returned sample confirmed the tubing ruptured.The tube exhibited stretching, and "ballooning" at the rupture site.The root cause of the reported issue could not be conclusively determined.All information reasonably known as of 23-jul-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
Halyard health received one partial, nasogastric (ng) tube sample.No product packaging was received.The product did not contain a lot number identification.During decontamination, it was not possible to flush fluid through the tubing.The distal portion of the ng tube was also received.The section measures approximately 29.5 cm in length.At the point of separation, the tubing "ballooned" or stretched and ruptured.The bolus tip was attached to the tubing.After decontamination, additional attempts were made to flush the tube.The occlusion remained and could not be dislodged.The tube pinched at various intervals to try to determine the location of the occlusion.At approximately 4cm from the distal tip, the tubing felt firm and could not be depressed.This was determined to be the proximal-most point for the occlusion.The bolus tip was examined under magnification.Dried brown matter was observed inside the opening of the bolus tip.The evaluation of the returned sample confirmed the tubing ruptured.The tube exhibited stretching, and "ballooning" at the rupture site.The root cause of the reported issue could not be conclusively determined.All information reasonably known as of 23-jul-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).

• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7402920
• Report Number: 9611594-2018-00053
• Device Sequence Number: 16573553
• Product Code: KNT
• UDI-Device Identifier: 10815149023998
• UDI-Public: 10815149023998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: Health Professional
• Device Model Number: 20-9438
• Device Catalogue Number: 104580600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 08/01/2018
• Patient Sequence Number: 1
• Patient Age: 40 YR