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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC. SPECTRUM; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
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COOK INC. SPECTRUM; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2017
Event Type  malfunction  
Event Description
This patient has a double lumen central venous line (cvl).Dad went to pick him up from the stroller/car and one of the lumens got caught under the wheel and snapped.The red lumen broke off.The rn in the pod clamped the lumen and pedi-surg was called.The lumen broke right above the bifurcation so the repair kits that we have available are not the right device to repair this.We needed a double lumen repair kit and central supply department (csd) was not familiar with how to obtain one.
 
Manufacturer Narrative
For type of device: catheter, urological (antimicrobial) and accessories.
 
Event Description
This patient has a double lumen central venous line (cvl).Dad went to pick him up from the stroller/car and one of the lumens got caught under the wheel and snapped.The red lumen broke off.The rn in the pod clamped the lumen and pedi-surg was called.The lumen broke right above the bifurcation so the repair kits that we have available are not the right device to repair this.We needed a double lumen repair kit and central supply department (csd) was not familiar with how to obtain one.
 
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Brand Name
SPECTRUM
Type of Device
CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
Manufacturer (Section D)
COOK INC.
1100 w morgan st
spencer IN 47460
MDR Report Key6776873
MDR Text Key82144718
Report Number6776873
Device Sequence Number0
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2017
Event Location Hospital
Date Report to Manufacturer07/28/2017
Type of Device Usage N
Patient Sequence Number1
Patient Age3 YR
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