MAUDE Adverse Event Report: HALYARD HEALTH, INC. SAF-T-PEXY T-FASTENERS; ETERNAL FEEDING PLACEMENT KIT

Model Number 98701

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

This is the third of three reports for the same patient involving three-separate products.Refer to report 9611594-2015-00024 for the first report.Refer to report 9611594-2015-00025 for the second report.(b)(4) health received a report stating three sets of t-fasteners broke when the g-tube was inserted.The doctor though it was a fluke the first time this happened but the incident occurred two more times.

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Results: no results available since no evaluation performed.Conclusion: device not returned.The actual complaint product was not returned for evaluation.A review of the device history record has been completed.The device history record for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.(b)(4) 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 (b)(4) health complaint database and identified as complaint comp-(b)(4).

• Brand Name: SAF-T-PEXY T-FASTENERS
• Type of Device: ETERNAL FEEDING PLACEMENT KIT
• Manufacturer (Section D): HALYARD HEALTH, INC.; alpharetta GA
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4528122
• MDR Text Key: 14882052
• Report Number: 9611594-2015-00026
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 98701
• Device Catalogue Number: 991098701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1