MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-3271-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that while removing a deltec® gripper micro® blunt cannula, non-coring safety needle, the needle was exposed and stuck the clinician.It was observed that the base and the safety arm were separated.No permanent injury was reported.
Additional Manufacturer Narrative
One used device was received for analysis.Visual inspection was performed and revealed no discrepancies.Functional testing was performed to verify if the safety mechanism could be re-activated.Pulling the base of the sample downwards, it was attempted to place the needle retractor back into place.The base and the needle were separated, and functional testing could not be performed.The complaint was confirmed.The most probable root cause to the reported issue has been attributed to damage which occurred after the device left the manufacturing facility.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
Additional Manufacturer Narrative
One used device was received for analysis.Visual inspection was performed and revealed no discrepancies.Functional testing was performed to verify if the safety mechanism could be re-activated.Pulling the base of the sample downwards, it was attempted to place the needle retractor back into place.The base and the needle were separated, and functional testing could not be performed.The complaint was confirmed.The most probable root cause to the reported issue has been attributed to damage which occurred after the device left the manufacturing facility.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6609212
• Report Number: 3012307300-2017-01156
• Device Sequence Number: 16353312
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: 10610586029882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-3271-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 04/26/2018; 04/26/2018
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 05/25/2018; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1