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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION; JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET
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SMITHS MEDICAL ASD, INC. TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION; JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET Back to Search Results
Catalog Number 982312D
Medical Device Problem Code Fail-Safe Design Failure (1222)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 08/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
See mfr: 3012307300-2017-01989 and 3012301300-2017-01990.
 
Event or Problem Description
It was reported that a clinician received a needle stick when using a saf-t wing® blood collection and infusion set.Clinician noticed there was a burr inside that's catching when the safety device was activated.Medical intervention was required.No other adverse health outcomes were reported.
 
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Brand Name
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Common Device Name
JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6838631
Report Number3012307300-2017-01988
Device Sequence Number10778252
Product Code JKA
UDI-Device Identifier15019517080988
UDI-Public15019517080988
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K081229
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/01/2017
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 Date06/16/2022
Device Catalogue Number982312D
Device Lot Number3449210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2017
Initial Report FDA Received Date09/01/2017
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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