MAUDE Adverse Event Report: HALYARD HEALTH MIC GASTROSTOMY FEEDING TUBE - 20 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0112-20
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 10 jul 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.(b)(4).
Event or Problem Description
It was reported that the device's balloon failed soon after initial placement, leading to the patient developing peritonitis and required surgery.No further information has been provided at this time.
Additional Manufacturer Narrative
The device history record for lot aa7345d04 was reviewed and the product was produced according to product specifications.One used device was returned for evaluation.The sample appearance was discolored.The balloon was filed with 7cc water and leakage was observed on the proximal collar area of the balloon.When viewed at 30x, a channel was observed in the bonded area of the collar.The complaint is confirmed.No root cause was determined.All information reasonably known as of 06 aug 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.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE - 20 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7681133
• Report Number: 9611594-2018-00085
• Device Sequence Number: 848899
• Product Code: KNT
• UDI-Device Identifier: 10680651948219
• UDI-Public: 10680651948219
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/01/2020
• Device Model Number: 0112-20
• Device Catalogue Number: 991094821
• Device Lot Number: AA7345D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR