MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; SYRINGE, STERILE, FIELD FLUSH 10 ML

Catalog Number EMZ10091280

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

It was reported; a patient had a reaction to 10 ml sterile saline syringe flush.Email received by clinical pharmacist specialist - critical care, (b)(6) hospital, with additional information in regards to this incident.Reporter states, "patient had a picc line placed in his right upper extremity and while flushing it with the sterile saline he immediately experienced flushing, mild swelling and itchiness of his lips and an itchy sensation all over his body.Patient began coughing and his heart rate increased." reporter states patient has never been exposed to this type of product in the past.Reporter states, "he did receive topical lidocaine about 45 minutes prior to the event." reporter states, "no wheezing or stridor, no urticaria, no swelling of tongue or uvula noted.We stopped flushing the picc line and he received diphenhydramine 50 mg and methylprednisolone 60 mg for a presumed allergic reaction." reporter states, "patient returned to his baseline about 30 minutes after this event and has had no further consequences related to this event." reporter states, patient has a tree nut allergy and denies all other reports of allergies.New syringes with same lot and expiration date are available for return.Evaluation report is pending at the time of this submission.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, a patient had a reaction to 10 ml sterile saline syringe flush.

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9 device available for evaluation -n/a.G6 type of report - follow-up.H2 if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer - yes, evaluation summery attached.H6 type of investigation- 4109, 4111, 3331.H5 investigation conclusion - zcd00007/not a product defect.H10 investigation report reads as follows: (b)(6) 2021 13:14:52 cst (jdesousa)."the customer reported that a patient with a tree nut allergy had a reaction to the sterile field saline flush syringe.Based on a review of the device history record there were no issues identified during the manufacture of the complaint lot, which could have caused the patient reaction, reported.An investigation of all manufacturing areas and processes as excelsior and excelsior suppliers determined that sufficient measures are in place at each facility to prevent any contamination, which could have resulted in the reported issue.Therefore, it is concluded that the sff products manufactured in lot#3139222 are free from contamination and safe for use.Based on the investigation performed, no failure was identified at any excelsior or excelsior supplier site; therefore, no corrective actions are required at this time.".

Event Description

It was reported, a patient had a reaction to 10 ml sterile saline syringe flush.

• Type of Device: SYRINGE, STERILE, FIELD FLUSH 10 ML
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 3310 s main st.; salisbury NC 28147
• MDR Report Key: 11753586
• MDR Text Key: 248321316
• Report Number: 1038445-2021-00003
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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 Catalogue Number: EMZ10091280
• Device Lot Number: 3139222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Weight: 71