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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 3055
Device Problems Material Separation (1562); Material Twisted/Bent (2981)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
No product was returned. Photos of device were attached for evaluation in poor condition; blurry and not clear. However, evidence was displayed that the catheter was severed 1/3 way from distal end. Other damage was noted at the point of severance and the remainder of the tubing was twisted and kinked. Investigation cannot confirm whether a quality related issue has resulted in the customer reported problem and therefore, root cause could not be defined with confidence.
 
Event Description
Information was received indicating that during an emergency department stay, a smiths medical jelco® protectiv® safety i. V. Catheter was reported to become sheared off in the patient. An ultrasound was performed; noting the foreign body. The physician numbed the area, performed a blunt dissection, obtained the remainder of the cannula and two sutures were placed. There were no further adverse patient effects.
 
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Brand NameJELCO® PROTECTIV® SAFETY I.V. CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA,
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key7932184
MDR Text Key122614625
Report Number3012307300-2018-03938
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/03/2018 Patient Sequence Number: 1
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