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

Device Problems Unintended Ejection (1234); Material Fragmentation (1261); Retraction Problem (1536); Fail-Safe Did Not Operate (4046)

Patient Problems Hematoma (1884); Pain (1994); Swelling (2091); Numbness (2415); Needle Stick/Puncture (2462)

Event Date 03/29/2018

Event Type  Injury  

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8537200
• MDR Text Key: 142671924
• Report Number: 3012307300-2019-01829
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: 10610586029882
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K072059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR