MAUDE Adverse Event Report: COOK INC WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fever (1858)

Event Date 10/06/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The word bgc catheter was placed at 11 a.M.Within the right side of the patient on (b)(6) 2014.On (b)(6) the patient returned and presented with lots of pus and febrile.It was noted that the word bgc catheter had fallen out.The patient was admitted for 3 nights with i.V antibiotics and discharged on (b)(6) 2014.No part of the device remained inside the patient.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of complaint history, functional testing, drawings, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "clean area surrounding bartholin gland with appropriate antiseptic solution.¿ the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The root cause could be related to the patient's condition at the time of this occurrence.Prior biocompatibility testing ensures that the device is biocompatible and will not cause adverse effects within the patient during use.Based on the information provided, the root cause cannot be definitively determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment no further action is required.

Event Description

The bgc catheter was placed at 11 a.M.Within the right side of the patient on (b)(6) 2014.On (b)(6) the patient returned and presented with lots of pus and febrile.It was noted that the bgc catheter had fallen out.The patient was admitted for 3 nights with i.V antibiotics and discharged on (b)(6) 2014.No part of the device remained inside the patient.

• Brand Name: WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5125302
• MDR Text Key: 27412778
• Report Number: 1820334-2015-00614
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K102141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-BGC-015055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2014
• Device Age: MO
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention