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

Catalog Number	305506
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential event dates: (b)(6) 2017; potential lot numbers: 3397315, 3423755, and 3471719; potential expiration dates: 03/20/2017, 05/15/2017, and 08/08/2017; potential manufacturing dates: 03/27/2017, 05/24/2017, and 08/11/2017.
Event or Problem Description
It was reported that a smiths medical jelco®protectiv® safety i.V.Catheter had "gushed" blood out of the flash chamber and onto the skin.The catheter was noted to be threaded to skin line with full needle retraction and lock out when the blood "gushed" pass the flash chamber and went into the housing unit.The catheter was removed and a new one was placed with no reported adverse patient effects.
Additional Manufacturer Narrative
One used jelco®protectiv® safety i.V.Catheter was returned for investigation.Functional testing found that the product failed to meet the expected performance.The root cause was determined to be an assembly fault attributed to the manufacturing of the device.The complaint was confirmed.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6912262
• Report Number: 3012307300-2017-02171
• Device Sequence Number: 99133
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: 10351688071095
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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
• Operator of Device: Nurse
• Device Catalogue Number: 305506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1