MAUDE Adverse Event Report: COVIDIEN 12ML SALINE SYRINGE (3ML); SALINE, VASCULAR ACCESS FLUSH

Model Number	8881570123
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the icn staff are concerned that there is a problem with this items plunger.They¿ve discovered during staff education and normal patient care that if the plunger pressure isn¿t maintained after priming, the plunger can retract and de-prime the extension set pulling fluid and air back into the syringe.This is occurring when the syringe is connected to make a closed system and all tubing connections are tight.There was no harm to the patient.
Additional 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.Cardinal health is committed to ensuring customer satisfaction by providing products of only the highest quality.Therefore, your feedback is essential and greatly appreciated.This feedback helps us to identify areas of improvements in our ongoing quality assurance efforts.

• Brand Name: 12ML SALINE SYRINGE (3ML)
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11584683
• Report Number: 1282497-2021-10015
• Device Sequence Number: 14644275
• Product Code: NGT
• UDI-Device Identifier: 30884521005550
• UDI-Public: 30884521005550
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881570123
• Device Catalogue Number: 8881570123
• Device Lot Number: 19E0624
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/21/2021
• Patient Sequence Number: 1