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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 12CC SALINE SYRINGE (10CC); SALINE, VASCULAR ACCESS FLUSH
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CARDINAL HEALTH 12CC SALINE SYRINGE (10CC); SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 8881570121
Device Problems Infusion or Flow Problem (2964); Air/Gas in Device (4062)
Patient Problem Insufficient Information (4580)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
Customer reports: the plunger slides back way too easily, de-priming the syringe, allowing it to fill with air if constant pressure is not on the plunger.Once the cap is removed and the small air bubble removed, the nurse has to keep positive pressure on the plunger as she¿s connecting to the iv.
 
Event Description
Customer reports: the plunger slides back way too easily, de-priming the syringe, allowing it to fill with air if constant pressure is not on the plunger.Once the cap is removed and the small air bubble removed, the nurse has to keep positive pressure on the plunger as she¿s connecting to the iv.Additional information was provided that air has been introduced into the fluid and that it occurs immediately when the syringe is held upright.There has not been any harm to a patient.
 
Manufacturer Narrative
Section b3/4/5/6: updated to include additional information as provided by the customer on (b)(6)20 21.The customer has stated that air has been introduced into the fluid and that it occurs immediately when the syringe is held upright.There has not been any harm to a patient.Section h6: updated to include an added device problem - air/gas in device.
 
Manufacturer Narrative
The investigation found that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records, including autoclave documents, were reviewed for the reported lot and no related event occurred during the overall process for this lot.Also, each lot is released based on an acceptable quality limit (aql) inspection.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.There were no samples or photographs returned for evaluation therefore we are unable to confirm the reported issue for this complaint.A supplier corrective action request (scar) was sent to the supplier of the syringes.The rubber tip is designed with a larger outside diameter than the syringe barrel internal diameter.This design is intentional and prevents any leakage during use while providing a good seal to maintain sterility of the finished product.This design causes the rubber tip to put pressure on the barrel walls.When the syringe goes through the autoclave process, heat is created which likely causes the syringe barrel wall to form over the rubber tip creating this bulge above the 3ml mark where the rubber tip resides.Depending on the actual dimensions of the rubber tip, barrel internal diameter and autoclave processing, the extent of bulge may vary.The bulge is found to be inherent to our sterilization process and therefore, it is not considered a deficiency.The root cause of the phenomenon reported in the complaint is due to our process that are within the aql.
 
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Brand Name
12CC SALINE SYRINGE (10CC)
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
MDR Report Key11992176
MDR Text Key259389891
Report Number1282497-2021-10276
Device Sequence Number1
Product Code NGT
UDI-Device Identifier10884521000261
UDI-Public10884521000261
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8881570121
Device Catalogue Number8881570121
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/09/2021
Patient Sequence Number1
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