MAUDE Adverse Event Report: HALYARD HEALTH UNKNOWN INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS

Model Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

All information reasonably known as of 8-nov-17 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 (b)(4).

Event Description

Per additional information received 30 oct 2017, the patient was almost (b)(6) with a severe neurological condition. The device was placed on (b)(6) 2017. The patient was returned to the hospital on (b)(6) 2017. A ct scan was performed, which identified the free gas in the patient's abdomen. An operation performed on (b)(6) 2017 identified the anchor in the ventricle wall.

Manufacturer Narrative

(b)(4). The actual complaint product was not returned for evaluation. Root cause could not be determined. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 17-oct-17 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). Device not returned.

Event Description

It was reported that a (b)(6) year old boy had an unknown mickey device inserted with unknown introducer kit at the hospital. Some days later, the patient arrived back at the hospital with free gas in the abdominal wall. During examination, one of the anchor sutures was found in abdominal wall. The hospital felt that this was the source of the gas. The gastrostomy, including sutures, was removed, and a new gastrostomy was made. The patient's status was unknown at the time this was reported to halyard. Additional information has been requested but not yet received.

• Brand Name: UNKNOWN INTRODUCER KIT
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industrial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6955843
• MDR Text Key: 113525952
• Report Number: 9611594-2017-00133
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2017
• 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?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/17/2017 Patient Sequence Number: 1