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 Problems Bacterial Infection (1735); Death (1802)

Event Date 11/03/2016

Event Type  Death  

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.Sterility testing on retained samples confirmed that there was no growth in the product.On 10-03-16, (b)(6) informed nurse assist that syringes from lot number 1607418 tested positive for b.Cepacia.(b)(6) sent the manufacturer unused syringes from one of the affected facilities for testing.The testing confirmed that the syringes distributed by (b)(4) (lot #: 1607418) contain burkholderia multivorans (a sub species of the burkholderia cepacia complex).Lot # 1607418 was not distributed to any other customers by the manufacturer.Our investigation is ongoing.Nurse assist initiated a voluntary recall for all lots of saline flush syringes.The removal was initiated on 10/04/2016.

Event Description

On 11-03-16, the centers for disease control (cdc) website noted 15 additional infection cases (yielding b.Cepacia in a patient who between august 1, 2016 and the present (11-03-16) received intravenous care at a facility that was utilizing prefilled 0.9% sodium chloride iv flush solution manufactured by nurse assist), and 1 additional death associated with the b.Cepacia infections previously reported by nurse assist (see mdr reports: 1650927-2016-00001 through 1650927-2016-00014).The cdc report noted that "it has not been determined whether the deaths associated with this outbreak were caused by the b.Cepacia infection, the patients' underlying health conditions, or another cause." despite efforts, manufacturer has been unable to obtain further information about the reported events.Because of this, and based on guidance from the fda, nurse assist is treating these reports as a literature source.No information is known about the specific cases or patients, thus a single mdr report will be filed for each cdc report.

• 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: 6140082
• MDR Text Key: 61297515
• Report Number: 1650927-2016-00015
• 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: literature
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/01/2016

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: 11/03/2016
• 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): Death; Other