MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GRIPPER MICRO NEEDLELESS Y-SITE LUER-ACTIVATED NEEDLELESS INJECTION SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3271-24
Medical Device Problem Codes	Unintended Ejection (1234); Material Fragmentation (1261); Retraction Problem (1536); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling (2091); Numbness (2415); Needle Stick/Puncture (2462)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photos were received for investigation and it was observed that the base of the gripper micro needleless y-site luer-activated needleless injection site was broken.In addition, one gripper micro needleless y-site luer-activated needleless injection site was returned for analysis in used condition.Visual inspection of the gripper needle showed that part of the base was broken and it was not possible to activate and deactivate the safety mechanism.Testing of inventory samples showed no discrepancies in activating the safety mechanism.No discrepancies were found during verification.Additionally, the production floor was also audited with (b)(4) units, finding no damaged bases.A review of the manufacturing process was conducted and was considered adequate and correct.A dhr review was also completed for the reported lot and no issues were found.Based on evidence and investigation, the complaint allegation was confirmed.The problem source is listed as unknown.However, it was noted that the most probable source of the complaint was damage occurring after the product left the manufacturing facility.User facility: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical gripper micro needleless y-site luer-activated needleless injection site's safety arm "suddenly broke apart from the inserter base" when the user was ready to de-access the chemo port and that "the sudden dislodgement" of the safety arm caused the needle to stick the user's right hand on the wrist.Immediately following the incident, the user reported an "intense numbness" on their hand and continued to carry out their work with no active bleeding or pain.The next morning, the user stated they had a "severe hematoma" and pain on their right hand.Gel was then applied to reduce the swelling.Subsequently, the user completed blood tests, took anti-inflammatory medicine, and was recommended to be closely monitored for six months.No additional adverse patient effects were reported.

• Brand Name: GRIPPER MICRO NEEDLELESS Y-SITE LUER-ACTIVATED NEEDLELESS INJECTION SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8537200
• Report Number: 3012307300-2019-01829
• Device Sequence Number: 18922624
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: 10610586029882
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 21-3271-24
• Device Catalogue Number: 21-3271-24
• Device Lot Number: 37X637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/22/2019
• 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 Age: 34 YR