MAUDE Adverse Event Report: FUTURE DIAGNOSTICS LLC CARE TOUCH LUER SLIP 3 ML DISPOSABLE SYRINGE; SYRINGE PISTON

Model Number CTSLS3

Device Problems Particulates (1451); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2018

Event Type  malfunction  

Event Description

We purchased caretouch 3ml luer slip syringes (ndc# (b)(4)), lot # 170522 from careline medical supplies.We were given a certificate of compliance that the syringes were sterile and compliant with fda mfg standards.Upon receiving the syringes, mold was noticed growing within one of the individually sealed syringes, as well as evidence of mold within the carton containing all the syringes as well as the outer shipper carton.While investigating other cartons and syringes from this lot number for signs of mold, it was also noted that 7 syringes were found to contain micro particles of black specks within the sealed syringe bags which proved that they are not sterile.

• Brand Name: CARE TOUCH LUER SLIP 3 ML DISPOSABLE SYRINGE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): FUTURE DIAGNOSTICS LLC
• MDR Report Key: 8231174
• MDR Text Key: 133072609
• Report Number: MW5082951
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 7039350201
• UDI-Public: 70393-502-01
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/22/2022
• Device Model Number: CTSLS3
• Device Lot Number: 170522
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other