MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* GASTRIC-JEJUNAL FEEDING TUBE KIT, SECUR-LOK* EXTENSION SETS ENFIT® CONN; DH EF BALLOON TUBES PRODUCTS

Model Number	104411300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No code available = patient required intubation, patient is unwell.The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 19 may 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 by (b)(6) hospital to their distributor that the jejunal tube tore and the patient aspirated, requiring intubation and ventilation.They allege the tear caused feed to go into the stomach instead of the jejunum.The patient became unwell, but no specific symptoms or treatment were reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
Correction: upon receipt of the sample, it was confirmed with the initial reporter that the original product code reported was incorrect.Model #/lot # has been updated with the correct product information.One used sample was returned for evaluation.Visual inspection revealed the molded head, tube, and balloon appeared to be discolored with foreign substances on the exterior and interior of the device.The balloon was filled with 5 cc of water and no leakage was observed.Feeding was simulated using water and methylene blue through the jejunal port.There was an observance of water droplets exciting the gastric skive area.The gastric skives were examined under magnification, and the inner wall of the tubing which separates the jejunal and gastric lumens had a tear which allowed for an inner lumen miscommunication/cross over.The manufacturing processes which could potentially contribute to this failure mode were reviewed during a process assessment performed by the quality engineer.The device was manufactured according to specification requirements and there were no tasks or deviations being performed that were abnormal to the established validated processes.Manufacturing conducts visual and functional inspections of each component throughout production.The complaint is confirmed, but no root cause has been determined.All information reasonably known as of 12jun2017 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
Per additional information received, the patient has remained in the hospital but has improved and is now self ventilating.The reporter feels that it's likely that the feed being given via the jejunal feeding tube was actually going into the stomach.No further information has been provided at this time.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6582842
• Report Number: 9611594-2017-00082
• Device Sequence Number: 13475472
• Product Code: KNT
• UDI-Device Identifier: 10680651956597
• UDI-Public: 10680651956597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: 104411300
• Device Catalogue Number: 8270-18-2.0-30
• Device Lot Number: AA6046N58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other