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

Model Number 8881570123

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event 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.

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)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11584683
• MDR Text Key: 243380310
• Report Number: 1282497-2021-10015
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30884521005550
• UDI-Public: 30884521005550
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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