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

Model Number E0100-01

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Nausea (1970); Pain (1994); Weakness (2145); Dizziness (2194); Loss of consciousness (2418); Sweating (2444)

Event Date 10/06/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, patient (b)(6) called excelsior medical stating that she went for an mri on (b)(6) 2014 and passed out after being injected with 10ml saline.According to the report, the nurse at the advanced medical imaging placed a cannula in (b)(6)'s left arm and started to inject with saline solution.As one-third of the solution was injected, (b)(6) started to feel dizzy.(b)(6) asked the nurse to stop the injection, and wanted to check her sugar level because (b)(6) has type 1 diabetes.The nurse still injected the rest of the saline into (b)(6) arm, and that is when (b)(6) blacked out, unconscious.The nurse then placed another tube in (b)(6) right arm, and administered another saline flush.(b)(6) blacked out again for about two to three minutes.The ambulance came, and (b)(6) was placed on a stretcher.(b)(6) sugar level was checked and it was 74.(b)(6) started feeling bad with a stomachache, sweating, weak, dizzy, and wanted to vomit.(b)(6) was asked which hospital she wanted to go to, but she wanted to go home and lay down.(b)(6) felt like she needed to drink water and a yogurt.Another glucose test was conducted, and it was found that (b)(6) glucose level went up to 126.(b)(6) waited for about 40 minutes while drinking water and having a yogurt, before being taken home by her husband.Since the incident, (b)(6) has reportedly been napping and lying down.(b)(6) informed excelsior medical via telephone (on (b)(6) 2014) that the mri was for her right wrist.Her doctor believes that she may have trigger finger because of the amount of pain she has in her wrist.(b)(6) shared that she has not experienced a fainting spell in the past.(b)(6) also shared that since the incident, red spots had appeared on her cheeks.Advanced medical imaging was contacted to obtain (b)(6) medical information, but advanced medical imaging informed excelsior that they could not share any patient information.In addition, the suspect devices are not expected to be returned to excelsior for evaluation.Excelsior is filing this adverse report out of an excess of caution that the reported event may have contributed to the need for medical intervention by advanced medical imaging.

Manufacturer Narrative

Excelsior is currently investigating the reported event.As part of the investigation, retention samples from the suspect lot were visually examined for the presence of contamination.No such defects were found during the examination.The saline solution in all retention samples was clear, and there was no indication of growth.Production records for the suspect lot are being reviewed for any discrepancies that could have caused or contributed to the reported event.In addition, available information regarding this event is being reviewed by excelsior's (b)(4).Upon completion of this investigation, a follow-up report will be filed.

Manufacturer Narrative

Since the initial submission, excelsior conducted a historical review of its complaint database to identify any similar incidents regarding the reported event.No similar incidents were found during the review period, which spanned from (b)(6) 2012 to (b)(6) 2014.In addition, no other complaints associated with lot 3120884 were reported.This finding indicates that the reported event is an isolated incident.Production records for the complaint lot, 3120884, were reviewed for any discrepancies that could have caused or contributed to the reported event.No such issues were identified.The records showed that the lot passed all quality testing before it was released for sale.Excelsior's medical director, dr.John wesley, reviewed the available information of this complaint and found no clinical risk of continuing to use excelsior's 10ml saline flush syringes as indicated for patient use.According to dr.(b)(6), the patient's signs and symptoms are classic for a hypoglycemic episode in a brittle diabetic.The only plausible cause-effect relationship with respect to the saline flush solution is that of transient regional hypoglycemia as the bolus of saline passed through the central nervous system.Slowing down the rate of injection of the saline flush solution would have allowed for appropriate dilution in the blood stream, and may have well prevented the reported event.Based on dr.(b)(6) assessment and the fact this event is an isolated incident, excelsior will not initiate any corrective or preventive actions.Excelsior now considers this matter closed.

• Brand Name: 10 IN A 10ML FLUSH SYRINGE
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION, USP
• Manufacturer (Section D): EXCELSIOR MEDICAL CORPORATION; 1933 heck avenue; neptune nj NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL CORPORATION; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: john linfante ; 1933 heck avenue; neptune, NJ 07753 ; 7326436088
• MDR Report Key: 4228263
• MDR Text Key: 5075594
• Report Number: 2027791-2014-00005
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: E0100-01
• Device Lot Number: 3120884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other