MAUDE Adverse Event Report: EXCELSIOR MEDICAL 10 IN A 10ML SALINE FLUSH; 0.9% SODIUM CHLORIDE INJECTION, USP

Model Number 8881579121

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Vomiting (2144); Chills (2191); Malaise (2359); Reaction (2414)

Event Type  Injury  

Event Description

It was reported to excelsior on (b)(6) 2013 that a customer had reported issue with a saline flush.The customer stated that a patient was ready to flush her line and became immediately ill and vomited after injecting the saline flush.The customer reported that the patient flushed the catheter and became ill; white stuff was vomited.The patient waited a few minutes and then injected two syringes and the customer became sick again.The patient¿s son called her doctor and the doctor told her to go to the emergency room.At home she did not have a fever, just the vomiting.When she got to the emergency room she got the chills.The customer went to the doctor, had a fever and chills at the er.The blood cultures were negative, but 6-10 hours later, she tested positive for yeast.As of (b)(6) 2013, the patient was still in the hospital, and was losing the line.Antifungals were prescribed for medication.The customer reported that the patient had also been using other pre-filled syringes which included the item (b)(4), heparin syringe, lot 13e1214n.Additional information from the customer states that the patient reported that the saline flush was the only flush involved.The patient is a long-term tpn patient who flushes her tunneled hickman catheter with saline flushes.Initially both blood cultures in the er were negative.However one of the two cultures later grew candida.The blood cultures were re-tested after 18 hours, at which point both cultures tested positive for yeast.The patient's catheter was surgically removed and replaced.In addition, she will require 6 weeks treatment of iv fluconazole.This incident was previously reported by the customer; reference number 1282497-2013-00052.

Manufacturer Narrative

An investigation is currently underway.Production records of the affected lot will be reviewed as part of this investigation.In addition, all information associated with this event will be reviewed by excelsior's medical director.Upon completion of the investigation, a follow-up report will be filed.

Manufacturer Narrative

Excelsior medical has completed its investigation into the reported incident.The below information is the investigation findings.The actual complaint samples were not returned; but one unused syringe from lot 3116476 was returned to excelsior for evaluation.Visual evaluation of the returned syringe did not show any signs of contamination in the saline fluid path.The entire retention sample population (100 syringes) of lot 3116476 was visually inspected for any signs of contamination in the saline fluid path.No defects were found.Production records for the lot were reviewed for any deviations or manufacturing discrepancies that could have caused the reported issues.None were found.Additionally, the records showed that the lot in question passed sterility and all other required quality testing prior to its release.A historical review of excelsior medical's complaint database revealed one similar incident specific to patients experiencing bad taste and vomiting after using excelsior's saline flush syringes.The investigation findings of this complaint, which was reported on 01/31/2012, found no evidence that the syringes associated with this report were in any way adulterated.In addition, no other reports of any issues with the complaint lot has been received.A clinical assessment conducted by excelsior's medical director, dr.(b)(6), concluded that it is possible that the patient's indwelling catheter was contaminated with biofilm harboring yeast, and that irrigation of the catheter with the subject saline flushes broke off several pieces of the growing biofilm.A published paper, role of catheter colonization and infrequent hematogenous seeding in catheter-related infections (e.Anaissie, et.Al), supports dr.(b)(6) conclusion regarding biofilm on the patient's catheter; this paper is attached for your reference.Dr.(b)(6) assessment also concluded that the subject flush syringes did not cause the clinical event in question, but functioned as intended by flushing and clearing the catheter of bits of biofilm which were already contaminated with growing yeast.The yeast contained in the shower of biofilm that were flushed into the patient's bloodstream most likely caused the clinical event that the patient experienced.Unfortunately, information regarding the condition of the patient's catheter was not provided to excelsior medical.As such, excelsior medical now considers this incident closed.

Event Description

It was reported to excelsior on (b)(6) 2013 that a customer had reported issue with a saline flush.The customer stated that a patient was ready to flush her line and became immediately ill and vomited after injecting the saline flush.The customer reported that the patient flushed the catheter and became ill; white stuff was vomited.The patient waited a few minutes and then injected two syringes and the customer became sick again.The patient's son called her doctor and the doctor told her to go to the emergency room.At home she did not have a fever, just the vomiting.When she got to the emergency room she got the chills.The customer went to the doctor, had a fever and chills at the er.The blood cultures were negative, but 6-10 hours later, she tested positive for yeast.As of (b)(6) 2013, the patient was still in the hospital, and was losing the line.Antifungals were prescribed for medication.The customer reported that the patient had also been using other pre-filled syringes which included the item 8881590125, heparin syringe, lot 13e1214n.Additional information from the customer states that the patient reported that the saline flush was the only flush involved.The patient is a long-term tpn patient who flushes her tunneled hickman catheter with saline flushes.Initially both blood cultures in the er were negative.However one of the two cultures later grew candida.The blood cultures were re-tested after 18 hours, at which point both cultures tested positive for yeast.The patient's catheter was surgically removed and replaced.In addition, she will require 6 weeks treatment of iv fluconazole.This incident was previously reported by the customer; reference number 1282497-2013-00052.

• Brand Name: 10 IN A 10ML SALINE FLUSH
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION, USP
• Manufacturer (Section D): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: john linfante ; 1933 heck avenue; neptune, NJ 07753 ; 7326436088
• MDR Report Key: 3550764
• MDR Text Key: 17570374
• Report Number: 2027791-2014-00001
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2015
• Device Model Number: 8881579121
• Device Catalogue Number: 8881579121
• Device Lot Number: 3116476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2013
• Initial Date FDA Received: 01/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other