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

Model Number	1210-BP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/21/2016
Type of Reportable Event	Death
Additional 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 (b)(6) 2016, the (b)(4) department of health (padoh) informed nurse assist that syringes from lot number 1607418 tested positive for b.Cepacia.Padoh sent the manufacturer unused syringes from one of the affected facilities for testing.The testing confirmed that the syringes distributed by pharmscript, llc (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.(b)(4).Nurse assist initiated a voluntary recall for all lots of saline flush syringes.The removal was initiated on (b)(6) 2016.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2016, the centers for disease control (cdc) website noted 3 additional infection cases (yielding b.Cepacia in a patient who between (b)(6) 2016 and the present ((b)(6) 2016) received intravenous care at a facility that was utilizing prefilled 0.9% sodium chloride iv flush solution manufactured by nurse assist) and one additional death associated with the b.Cepacia infections previously reported by nurse assist (see mdr reports: 1650927-2016-00001 through 1650927-2016-00018).According to the cdc, it is not known whether the death was the result of the infection or of another underlying 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
• Common Device Name: NORMAL SALINE FLUSH SYRINGE
• Manufacturer (Section D): NURSE ASSIST, INC.; 4409 haltom rd.; haltom city TX 76117
• MDR Report Key: 6214768
• Report Number: 1650927-2016-00019
• Device Sequence Number: 741647
• Product Code: NGT
• UDI-Device Identifier: 0+B1501210BP0C
• UDI-Public: +B1501210BP0C
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/29/2016

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 12/29/2016
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1650927-10/14/2016-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other