MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 21-3256-24

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 03/20/2023

Event Type  Injury  

Event Description

It was reported that the nurse was de-accessing a port and the safety mechanism failed, resulting in needlestick and bodily fluid exposure.There was a clinical injury.Patient had bloodborne disease, resulting in exposure of the healthcare team member.Treatment included medical prophylaxis for bloodborne pathogen.The patient did not receive any medical treatment.The event is listed as ongoing due to continued medical prophylaxis of healthcare team member.The patient information was unknown.

Manufacturer Narrative

Other text: d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Not confirm the reported complaint.A device history record (dhr) review could not be performed as the lot number is unknown.If the product is returned, the manufacturer will reopen the complaint for further investigation.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16869834
• MDR Text Key: 314571535
• Report Number: 3012307300-2023-05085
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029790
• UDI-Public: 10610586029790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-3256-24
• Device Catalogue Number: 21-3256-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention