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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
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COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); No Code Available (3191)
Event Date 06/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).The event is currently under investigation.
 
Event Description
Information was provided that during induction of labour and post partum hemorrhage (pph), there was complications and the patient went back to theatre for reopening with repeat laparotomy and opening into the uterus and ended up in sepsis and intensive therapy unit (itu).Additional information has been requested but not provided by the reporter.
 
Manufacturer Narrative
(b)(4).A review of the complaint history, instruction for use (ifu), documentation, specifications and quality control was conducted during the investigation.This case was reviewed by outside professional clinical review.The clinical opinion was that it is ¿reasonable to suggest that this was due to the procedure/technique of the healthcare professional and as a result patient ended up in intensive therapy unit (itu) with sepsis.This was an additional intervention done to remove the balloon.¿ the device is shipped with an instruction for use that instructs to avoid puncturing the balloon while suturing for a transabdominal placement of the device.In addition, the ifu advises to not use the device if there is doubt as to whether the product is sterile.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.A review of the device history record was not possible as the lot number was not supplied.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Based on the provided level of information it is feasible that user technique contributed to this incident; however, a definitive root cause cannot be determined or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
 
Event Description
Information was provided that during induction of labour and post partum hemorrhage (pph), there was complications and the patient went back to theatre for reopening with repeat laparotomy and opening into the uterus and ended up in sepsis and intensive therapy unit (itu).Additional information has been requested but not provided by the reporter.
 
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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
rita harden
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key5741598
MDR Text Key47930562
Report Number1820334-2016-00595
Device Sequence Number1
Product Code KNA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K062438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberJ-SOSR-100500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/10/2016
Event Location Hospital
Date Manufacturer Received06/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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