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

Model Number	21-3256-24
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem 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.Time of event was 8:30.
Additional Manufacturer Narrative
Evaluation codes: updated.No product was returned and could 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
• Common Device Name: 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: 16856000
• Report Number: 3012307300-2023-04916
• Device Sequence Number: 12677236
• Product Code: FPA
• UDI-Device Identifier: 10610586029790
• UDI-Public: 10610586029790
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown