MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

Information was received indicating that after removing a smiths medical deltec gripper plus safety needle from the chamber, the nurse sustained a needle stick to the left index finger.It was reported that the cause may have been due to the safety needle dysfunction.There were no further reported adverse effects.

Manufacturer Narrative

Other, other text: one used sample was returned for evaluation.Examination showed the device's metal needle was retracted past the needle base.The needle arm was pulled past the capture point.During production, the gripper safety needles are sampled for functional testing (hinge activation testing) to verify the parts are free of damage and workmanship defects and the manufacturing procedures are being followed.The device instructions for use document was reviewed and the following relevant warning was identified: "failure to use safety arm correctly (lift safety arm straight back to the lock position until it clicks) while removing needle from portal site could result in the needle tip re-emerging from the base, resulting in accidental needlestick with contaminated needle." the investigator took 2 samples from production and used the safety arm incorrectly (applied excessive force during withdrawal of the metal needle).The testing was able to induce the condition seen in the returned sample; the metal needle went past the safety point and was left exposed.The investigation determined the most likely cause of the issue was damage during use.

• Brand Name: DELTEC GRIPPER PLUS SAFETY NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10179166
• MDR Text Key: 195934169
• Report Number: 3012307300-2020-06117
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1