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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JARIT JARIT CARB-BITE DEBAKEY NEEDLE HOLDER 10.5" ; CARB BILE DEBAKEY NEEDLE HOLDER
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JARIT JARIT CARB-BITE DEBAKEY NEEDLE HOLDER 10.5" ; CARB BILE DEBAKEY NEEDLE HOLDER Back to Search Results
Catalog Number 121-188
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/13/2017
Event Type  malfunction  
Event Description
Patient in surgery for an exploratory laparotomy.While using a jarit catalog #121-188 carb-bite debakey 10 1/2" needle holder multiuse during this case, a small piece of metal broke off into the abdomen.The piece was retrieved by the surgeon in its entirety.Prior to closure an abdominal kub x-ray was performed and read immediately by a radiologist.Findings were postsurgical changes without radiopaque foreign body.No harm to the patient.Instrument taken out of use.Manager of central sterile supply notified about incident.All instruments are checked for integrity during sterilization processing and packaging.
 
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Brand Name
JARIT CARB-BITE DEBAKEY NEEDLE HOLDER 10.5"
Type of Device
CARB BILE DEBAKEY NEEDLE HOLDER
Manufacturer (Section D)
JARIT
MDR Report Key7037450
MDR Text Key92475567
Report NumberMW5073353
Device Sequence Number1
Product Code FHQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/14/2017
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? Yes
Device Operator Health Professional
Device Catalogue Number121-188
Device Lot Number121-188
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/15/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight100
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