MAUDE Adverse Event Report: BENLAN, INC. DEROYAL; GASTROINTESTINAL TUBE AND ACCESSORIE

Catalog Number 54-7066

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

The medical center reported that all sizes of the deroyal neonatal feeding tubes (adaptor end) are stretching out once the extension set with clamp styas connected for a span of time.Due to the issue, the clinicians are having to use both hands to draw the residual back.

Manufacturer Narrative

Describe event or problem: the medical center reported that all sizes of the deroyal neonatal feeding tubes (adaptor end) are stretching out once the extension set with clamp styas connected for a span of time.Due to the issue, the clinicians are having to use both hands to draw the residual back.Deroyal: the reported device has not been returned to deroyal at this time for evaluation.The investigation into the root cause is in process.It has been identified that after removing the extension set, if the connector is not given time to shrink back to its original size and the clinician uses a small syringe (1-10cc) then the connector may be loose and they will not be able to get a good draw.Testing is being performed to compare the use of 1-10cc syringes to the 20-60cc enteral syringes and extension sets.

• Brand Name: DEROYAL
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIE
• Manufacturer (Section D): BENLAN, INC.; CA
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3899033
• MDR Text Key: 20702288
• Report Number: 1060680-2014-00011
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54-7066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2014
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other