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

Model Number	42-9368
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient codes: no code available - patient required an endoscopy procedure.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 06-nov-2017 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 via (b)(6) that a patient was receiving enteral nutrition via a corflo enteral feeding tube.Feed was found to be coming out of the patient's mouth and around the tracheostomy tube.An x-ray was performed and confirmed that there was no tube visible in the patient's esophagus.However, the tip was viewed to be in the patient's stomach and appeared to be dissected.The patient required an endoscopy procedure under sedation to retrieve the lower portion of the feeding tube.
Additional Manufacturer Narrative
Sample returned.All information reasonably known as of 20-mar-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
The sample was received in two parts.The breaking area was photographed as well to see if there were foreign matter build up, no foreign matter build up was seen.During decontamination, the central port of the enfit connector was flushed with solution using an enfit syringe, there was slight resistance felt.Some whitish material came out of the proximal end breaking point.The distal end of tube was flushed as well, no whitish or any material build up came out on the bolus tip.The sample was examined under ambient light conditions.The tubing is separated at the 36cm 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 is missing.Based on the depth markers on both sections of the sample, it appears that the full tube is present.Brown discoloration was observed at the proximal end, below the feed port and again between the 60cm and 63cm markers.Between the 58cm and 59cm markers, an irregularity in the tubing was observed.The tube appears pinched creating a ridge in the tube wall.There are axial depressions in the outer surface of the tubing.The depressions have a distinct outline.The root cause was attributed to inappropriate use.This issue was caused by excessive pressure caused by trying to unclog the tube by flushing.All information reasonably known as of 05-apr-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
All information reasonably known as of 16-jan-2017 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).
Event or Problem Description
Additional information received on 18-dec-2017 via the (b)(6) regarding a draft article of a fault with an enfit system nasogastric tube failure.It was reported that a nasogastric tube tore in a patient.The patient also had a tracheotomy.The draft article stated, "we noticed nasogastric feed exuding from a tracheotomy site in a patient who could not swallow safely, and who complained of feeling something trickle down the back of his throat.A chest radiograph (fig.1a) showed the tip of the ngt positioned below the diaphragm, but with two distinct ends in the stomach and duodenum, respectively.The proximal end was withdrawn and revealed a dilated and ruptured tube; the distal tip was removed by endoscopy and showed a dilated ¿aneurysm¿ with a blockage distal to the tip, most likely a crushed tablet (fig.1b).The patient suffered no adverse consequences." additional information received on 05-jan-2018 stated that the patient was an elderly gentleman (age not specified).At the time of patient discharge, the patient was well.It was noted that the nasogastric tube ballooned and ruptured halfway down it's length.It was blocked with medicine.Additional information received on 11-jan-2018 from the hospital stated that the patient's condition has improved significantly and he is now able to sit on his chair.He is being optimized for discharge to the core medical ward.The patient is continuing on intravenous antibiotics (meropenem) for the community acquired pneumonia.There was no indication that his chest worsened following the event.No further information has been received at this time.

• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7007847
• Report Number: 3009124963-2017-00052
• Device Sequence Number: 16511347
• Product Code: KNT
• UDI-Device Identifier: 20815149020673
• UDI-Public: 20815149020673
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2018

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: 42-9368
• Device Catalogue Number: 104609200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/18/2017; 03/05/2018; 03/27/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/17/2018; 03/21/2018; 04/12/2018
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 59