MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2762-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that during a chemotherapy treatment, the safety device of a deltec® gripper plus® safety needle did not engage and the needle pricked the nurse.The nurse went to the emergency room and accidental blood exposure protocol has been followed.No permanent injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition and without its original packaging.Visual inspection found that the safety mechanism had not been activated and the device was free of damage.Functional testing involved use testing and found that the safety mechanism was activated without problem.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.Based on the evidence, no fault was found and the root cause was unable to be determined.

• Brand Name: DELTEC® GRIPPER PLUS® 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: 6634846
• Report Number: 3012307300-2017-01235
• Device Sequence Number: 16294230
• Product Code: FPA
• UDI-Device Identifier: 10610586025556
• UDI-Public: 10610586025556
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• 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
• Report Date (Section B): 10/23/2017

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?: Yes
• Operator of Device: Nurse
• Device Catalogue Number: 21-2762-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other