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

Catalog Number J-BGC-015055

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient code: necrosis not labeled, infection not labeled.Device code: adverse event without identified device or use problem (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a j-bgc-015055 was placed in an abscess of one of the bartholin´s glands on a patient on (b)(6).The doctor who placed the catheter flushed the cavity with saline before placement to make sure all pus was removed.Five days later, the patient came back with necrosis and infection around the catheter.The catheter was removed and the patient was given pain killers and antibiotics, but no other procedures besides that.It´s unclear if the product was the cause of this necrosis/infection.Update: after following up, additional information was received on 20sep2018.The patient doesn´t smoke and is overall healthy.The area was cleaned and the scalpel was used to puncture the abscess.The abscess was drained and the cavity was flushed with saline to make sure all pus was removed.Then the catheter was inserted and filled.The secretion to be drained was yellow, thick secretion.The cavity was emptied from pus and flushed with saline.Patient was told to keep the area clean.The catheter kept the abscess open although it blocked the drainage.The device was without any remarks.Post-diagnosis of necrosis, the patient was prescribed tablet diclocil (dicloxacillin) 1 g x 4 for 10 days.Patient came back (b)(6) and she was much better.The abscess had healed good and she didn´t have any redness or pain.

Manufacturer Narrative

Investigation evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use and quality control data.A review of the device history record could not be performed as the lot number of the device was not provided.A review of complaint history could not be performed on the complaint device lot because the lot number was not provided.Current process and quality inspection checks are in place to ensure the functionally and device integrity prior to shipment.The cause for this specific failure mode cannot be established at this time.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no new information received since the last report was submitted.

• 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
• MDR Report Key: 7894466
• MDR Text Key: 120893861
• Report Number: 1820334-2018-02827
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K102141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-BGC-015055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR