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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Pain (1994); Peritonitis (2252); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 29-dec-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 that a patient experienced an incident where 4 sutures fell off within 24 hours of the procedure.The cancer patient required another radiologically inserted gastrostomy, which meant the requirement of general anesthetic.Additional information received on 13-dec-2017 stated that the upon checking, all t bars were still in the abdominal wall.The sutures and locking discs were not kept and no pictures taken since they came out with the dressing, which was all disposed of.The patient experienced pain since this event occurred over the weekend.The patient developed peritonitis, had gastric leakage, and also had to have a laparoscopic procedure.She will have to wait between a few weeks to a month before attempting another tube placement.No additional information was 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7156553
• MDR Text Key: 96147570
• Report Number: 9611594-2017-00172
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention