MAUDE Adverse Event Report: HALYARD HEALTH PED. TRANSGASTRIC JEJUNAL, 16F INTERNATIONAL; DIGESTHEALTH ENTERAL FEED

Model Number 0650-16-15

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: unknown.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.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 Description

It was reported by the parents of the patient that the gj-tube cracked below the adaptor after 3.5 months in situ.The parents reported that they attempted to fix the adaptor with tape, but were unsuccessful, as the tube is too heavy for the tape.They have alleged that the child was not touching or pulling at the tube.The tube was replaced.No further information is available at this time.

• Brand Name: PED. TRANSGASTRIC JEJUNAL, 16F INTERNATIONAL
• Type of Device: DIGESTHEALTH ENTERAL FEED
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales CP 84 048; MX CP 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5532744
• MDR Text Key: 41676286
• Report Number: 9611594-2016-00058
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: PK921370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0650-16-15
• Device Catalogue Number: 991095835
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR