MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION; JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET

Catalog Number 982312D

Device Problem Fail-Safe Design Failure (1222)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2017-01989 and 3012301300-2017-01990.

Event 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.

• Brand Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Type of Device: JELCO® SAF-T WING® BLOOD COLLECTION AND INFUSION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6838631
• MDR Text Key: 84368295
• Report Number: 3012307300-2017-01988
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 15019517080988
• UDI-Public: 15019517080988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Catalogue Number: 982312D
• Device Lot Number: 3449210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention