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	308700
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intravascular (iv) catheter was used with a patient when the hub detached from the "angio" catheter immediately upon use.The iv was started with an "angio" needle.The user was able to obtain blood return and advanced the catheter until "it clicked".The needle was retracted without loosening the connection or detaching the "angio" needle from the hub.Due to the incident, blood loss occurred at the patient's hand.The user applied digital pressure to minimize blood loss.The user was able to connect the iv tubing to the hub and taped the tubing to the patient's hand.No medical intervention was required.No patient or clinician injury occurred.
Additional Manufacturer Narrative
Three unused catheters were received for investigation.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.Upon examination of the returned product found no visual non-conformances.During functional analysis, no issues were observed with the connection of the tubing or the overall function of the catheters.This investigation did confirm that the product failed to meet the expected performance.However, no issues were observed during inspection of the returned sister catheters and root cause was unable to be confirmed.No issues were identified that would have impacted this event.No correction or corrective actions will be conducted by the manufacturing facility at this time.

• 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: 6797998
• Report Number: 3012307300-2017-01767
• Device Sequence Number: 10791647
• Product Code: FOZ
• UDI-Device Identifier: 10351688071323
• UDI-Public: 10351688071323
• Combination Product (Y/N): N
• 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): 11/16/2017

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: Health Professional
• Device Expiration Date: 05/25/2020
• Device Catalogue Number: 308700
• Device Lot Number: 3417461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20G "ANGIO"