MAUDE Adverse Event Report: NURSE ASSIST, INC. NURSE ASSIST; NORMAL SALINE FLUSH SYRINGE

Model Number 1210-BP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

Nurse assist saline flush syringes are single-use devices.The company does not know if the products were reprocessed or reused on patients.No used syringes were returned to the manufacturer.Manufacturer tested retained samples for bioburden, and there was no presence of b.Cepacia in those samples.On 10-03-2016, (b)(6) informed nurse assist that syringes from lot number 1607418 tested positive for b.Cepacia.(b)(6) sent the company unused syringes from one of the affected facilities, and testing on those products is on-going.Manufacturer is also aware that (b)(6) have issued notices regarding cases of b.Cepacia infection that may be associated with nurse assist saline flush syringes, and investigations are still on-going.No code available; our investigation is ongoing.This form was originally submitted via (b)(6) delivery on 10/28/2016.The form was returned and nurse assist was informed that it must be submitted online.This is the first emdr submission for nurse assist.Final submission is made 12/01/2016 as soon as the registration and test submission process was completed.Additional submissions will follow as needed.Nurse assist initiated a voluntary recall for all lots of saline flush syringes.The removal was initiated on 10/04/2016.

Event Description

On 09-28-2016, (b)(4) (a distributor) verbally reported to nurse assist that, between(b)(6) 2016, 11 patients had experienced infections that were potentially related to nurse assist's saline flush syringes.The facilities began using p/n 1210-bp on (b)(6) 2016.(b)(4) noted that there was no direct evidence that the syringes are a root cause, but that they are common to the patients with the infections.Despite efforts, manufacturer has been unable to obtain further information about the reported events from (b)(4).Accordingly, the 3500a form for each of the 11 reported infections will contain the same information.

• Brand Name: NURSE ASSIST
• Type of Device: NORMAL SALINE FLUSH SYRINGE
• Manufacturer (Section D): NURSE ASSIST, INC.; 4409 haltom rd.; haltom city TX 76117
• Manufacturer (Section G): NURSE ASSIST; 4409 haltom rd.; haltom city TX 76117
• Manufacturer Contact: matt picha ; 4409 haltom rd.; haltom city, TX 76117 ; 8172311300
• MDR Report Key: 6138136
• MDR Text Key: 61310310
• Report Number: 1650927-2016-00008
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 0+B1501210BP0C
• UDI-Public: +B1501210BP0C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 1210-BP
• Device Catalogue Number: 1210-BP
• Device Lot Number: 1607418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: 1650927-10/14/2016-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other