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

Model Number N/A

Device Problems Blocked Connection (2888); Device Operational Issue (2914)

Patient Problems Blood Loss (2597); No Patient Involvement (2645)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the customer attempted to use the cook bakri postpartum balloon with rapid instillation components to stop the post-partum hemorrhage in the patient.The operating room nurse tried to assemble the bakri balloon with the filterline tube and a three way valve.It was discovered that the spike on the filterline tube was blocked therefore the fluid didn't come out of the saline bag into the tube.The operating room nurse opened a new bakri balloon package and connected a new filterline tube to it.The device did not come in contact with the patient.It was reported that the procedure took more time to stop the bleeding in the patient due to this occurrence.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No additional information has been provided regarding patient outcome.

Manufacturer Narrative

Outcomes to adverse event: extended surgical time.Investigation ¿ evaluation: this investigation included a documentation review of complaint history, the device history record, quality control data, and specifications.In addition, a visual inspection of the returned device was also conducted.Only the rapid instillation component part of the device was returned for investigation.The device was wired with a stock.038¿ wire guide and the line was found to be blocked at the spike.Only 6 cm of wire went into device.There appears to be glue inside the fitting.The investigator attempted to wire with a.025¿ wire without success.The inner diameter of the fitting would not pin with the appropriate pin gauge.Using magnification, the hole appears to be occluded, however the substance occluding the hole was not determined.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.The device history record review found there were no non-conformances associated with the device lot number 7609328.A review of complaint history for this product/lot number combination revealed there have been no other complaints received.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6654199
• MDR Text Key: 78015024
• Report Number: 1820334-2017-01441
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)200120(10)7609328
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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): Other