MAUDE Adverse Event Report: UNOMEDICAL S.R.O. OR/GASTRO/STOMACH; TUBE, FEEDING

Model Number 23038339

Device Problems Retraction Problem (1536); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

It was reported "stomach tube with too sharp-edged stylet." it was also reported that the mandarin comes out through the lateral eye of the gastric tube.

Manufacturer Narrative

Additional information received via email on (b)(6) 2014, mandarin is kind of introducer what helps to insert catheter into the body.It should stay inside the catheter tube.A quality evaluation was performed on (b)(6) 2014.Based on the available information, this event is deemed a reportable malfunction.The picture of an affected sample has been received and evaluated.The defect reported by customer has been confirmed.The mandarin comes out through the lateral eye of the gastric tube.The lot has not been provided; therefore, the device history records cannot be reviewed.The stomach catheter consists of two parts: catheter and mandarin.Catheters are produced at machine and 100% visually tested.The mandarin is manually inserted in the tube through the connector until it is right in the bottom as per relevant work instructions.After assembling the catheters are packed in peelpack.Each catheter is manually packed into the bow-shape in order to fit the form.The product is checked by operators.The issue was discussed within team consisting of quality assurance and production staff and they confirmed that this type of failure has never been observed in our production.We have never received similar complaint on the product.Based on above we cannot determine the possible root cause of the failure.The failure is not included in relevant risk management file.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: OR/GASTRO/STOMACH
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3869010
• MDR Text Key: 4458189
• Report Number: 3005778470-2014-00017
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K896734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23038339
• Device Catalogue Number: 23038339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1