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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
Catalog Number J-SOSR-100500
Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Hole In Material (1293)
Patient Problem No Patient Involvement (2645)
Event Date 05/18/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that prior to patient contact, when inserting the spike into the device for the postpartum hemorrhage procedure, drips of water were coming out of the tubing where the junction of the spike was located.It was further noted that the tubing had a fine hole and it started to come off, eventually disconnecting from the spike piece.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7213498
MDR Text Key98521567
Report Number1820334-2018-00257
Device Sequence Number1
Product Code KNA
UDI-Device Identifier10827002242378
UDI-Public(01)10827002242378(17)171117(10)5438452
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2018
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 NumberJ-SOSR-100500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2018
Initial Date FDA Received01/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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