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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS; CATHETER, CONDUCTION, ANESTHETIC
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SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Catalog Number 6947-02
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 06/19/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received indicating that the sleeve of a smiths medical portex® epidural catheter broke off during a procedure with the physician unable to extract it.Subsequently, further attempts were made to attempt to remove retained catheter sleeve with no success.There were no reported adverse patient complications.
 
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Brand Name
PORTEX® EPIDURAL MINIPACKS
Common Device Name
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key8823224
Report Number3012307300-2019-02946
Device Sequence Number3109483
Product Code BSO
UDI-Device Identifier00351688056071
UDI-Public00351688056071
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
D029630
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date02/08/2022
Device Catalogue Number6947-02
Device Lot Number3777641
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2019
Initial Report FDA Received Date07/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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