RLSND122-2.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-13 for RLSND122-2.5 manufactured by Rhythmlink International, Llc.

Event Text Entries

[36507808] The actual date of the event is unknown. A voicemail was left for (b)(4), an employee of rhythmlink on (b)(6) 2015, by (b)(4) with (b)(6) hospital. She said that they had a needle break off into a patient and that the needle had been removed and the patient was ok.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1067162-2016-00001
• MDR Report Key: 5382511
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2016-01-13
• Date of Report: 2016-01-13
• Date of Event: 2015-12-14
• Date Mfgr Received: 2015-12-14
• Device Manufacturer Date: 2015-07-30
• Date Added to Maude: 2016-01-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 1140 1ST. SOUTH
• Manufacturer City: COLUMBIA SC 29209
• Manufacturer Country: US
• Manufacturer Postal: 29209
• Manufacturer Phone: 8032521222
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RLSND122-2.5
• Generic Name: SUBDERMAL NEEDLE
• Product Code: GXZ
• Date Received: 2016-01-13
• Model Number: RLSND122-2.5
• Lot Number: 00004903
• Device Expiration Date: 2017-07-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RHYTHMLINK INTERNATIONAL, LLC
• Manufacturer Address: COLUMBIA SC 29209 US 29209

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-01-13