MAUDE Adverse Event Report: HALYARD HEALTH MIC* PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT® CONNECTORS; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number 9640-14

Device Problem Split (2537)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 30-oct-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 Description

It was reported by the doctor that following an uneventful peg tube insertion on a (b)(6) male patient, the tube began leaking within the first few hours of use.The peg tube was used for clear fluids post-operatively and then for medication.The leak was managed by dressings at first, but the patient developed a wound infection necessitating a prolonged hospital stay and iv antibiotics.The gastrostomy site continued to leak gastric fluid, and the child was given an iv line and was kept nothing by mouth with the tube on free drainage for a few days.A wound care nurse was required to dress the site, which constantly leaked, especially after the patient resumed oral fluids.During one of the dressing changes, a split was noted in the tube.The doctor could not replace the tube due to risk of failure of the new gastrostomy.The doctor waited two weeks and then the tube was carefully replaced without incident, and the patient is currently doing well.No further information has been provided at this time.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for 0202595229 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

Manufacturer Narrative

One used sample was returned for evaluation.Visual inspection revealed that the y adapter appeared to have a foreign substance on the interior and the external bolster appeared to be discolored.While examining the distal end of the device (the bumper), it was noted that there was damage around the joining area of the tubing and bumper.The bumper appeared torn from the tubing and was separating at the bonded area.Under 50x magnification, it was noted that there were cutting effects in the tubing above the bumper.The reported event was confirmed for a split in the peg tube.However, no root cause could be determined at this time.All information reasonably known as of (b)(6) 2018 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Type of Device: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite; tucson AZ 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6988450
• MDR Text Key: 90600578
• Report Number: 3006646024-2017-00020
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K924065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 9640-14
• Device Catalogue Number: 104464400
• Device Lot Number: 0202595229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR