MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOSR-100500

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(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 sometime in (b)(6) 2017 they used the cook bakri postpartum balloon with rapid instillation components after a c-section.They placed the balloon fine, but later found the blue stop cock in the patients uterus.No further information has been provided.Additional patient, device and event information has been requested but not received at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation.The cook bakri postpartum balloon with rapid instillation components was not returned.No photographs or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A review of the instructions for use and specifications was conducted.A device history record review was unable to be performed as the complaint device lot number was not provided.A review of complaint history records for the complaint device lot number also could not be performed without the associated device lot number.A review of relevant manufacturing documents was conducted.The device is inspected visually and tested functionally by the supplier for leaking and inflation.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.The ifu states the following under the transabdominal placement, post-cesarean section: determine uterine volume by direct examination.From above, via access of the cesarean incision, pass the tamponade, inflation port first, through the uterus and cervix.Note: remove the stopcock to aid in placement and reattach prior to filling balloon.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.Based on the provided information root cause can likely be attributed to personnel not following the ifu; by not removing the stopcock for transabdominal placement.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Investigation ¿ evaluation.The cook bakri postpartum balloon with rapid instillation components was not returned.No photographs or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A review of the instructions for use and specifications was conducted.A device history record review was unable to be performed as the complaint device lot number was not provided.A review of complaint history records for the complaint device lot number also could not be performed without the associated device lot number.A review of relevant manufacturing documents was conducted.The device is inspected visually and tested functionally by the supplier for leaking and inflation.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.The ifu states the following under the transabdominal placement, post-cesarean section: determine uterine volume by direct examination.From above, via access of the cesarean incision, pass the tamponade, inflation port first, through the uterus and cervix.Note: remove the stopcock to aid in placement and reattach prior to filling balloon.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.Based on the provided information root cause can likely be attributed to personnel not following the ifu; by not removing the stopcock for transabdominal placement.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7289306
• MDR Text Key: 100912846
• Report Number: 1820334-2018-00461
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 04/23/2018
• Patient Sequence Number: 1