MAUDE Adverse Event Report: COVIDIEN 12CC SALINE SYRINGE (10CC); SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570121

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2019

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 that after removing the air from the syringe the plunger slide back into the barrel of the syringe allowing air back into the syringe.

Manufacturer Narrative

The supplier completed the investigation and relayed the following results: a review of the device history record (dhr) for lot no.18d0814 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Additionally, the equipment/instrument investigation identified the equipment was in proper functioning condition during the manufacturing, filling and packaging of the lot.A review specifically for plunger and syringe issues was performed in the manufacturing records and nothing out of the ordinary has occurred.Also, each lot is released based on an aql sampling, including the verification for incomplete assembly or substandard components.As per the final quality inspection report of this lot, all criteria were conforming.There¿s no indication of a systemic issue with the product or process.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Review of the incoming inspection reports for the syringes used in this batch showed that they were in conformance and were released accordingly.The manufacturing records were reviewed and nothing out of the ordinary has occurred.All tests performed on the finished product were within their limits at release.Equipment was in proper functioning condition during the manufacturing, filling and packaging of the above mentioned lot.Personnel involved in the manufacturing, filling, and packaging of this lot have received adequate training to perform the various activities.517 unused syringes were returned to the manufacturing site for evaluation.Twenty syringes were visually examined, and no defects were observed.Ten syringes were tested to reproduce the reported defect and all syringes gave the same result.After removing the tip cap, the syringe was held in a vertical position and the air was pushed outside the syringe by pushing the plunger inside the syringe.The plunger was then let go and the following was observed: the plunger slides back a little inside the syringe and air comes back inside the syringe.This observation is very similar to the complaint description.To obtain more information about the compliance status of the syringes, returned samples underwent further testing.Forty returned samples were visually inspected, and a slight deformation was observed where the rubber tip rested.Plunger was also pushed near the 9-10ml mark and plunger receded on all samples.Past the 9ml mark, plunger movement was not observed.Five syringes were measured for barrel diameter at 10ml and at 4ml.The difference between the two marks in inches varied from 0.015 to 0.017.The tolerance for the barrel outside diameter is +/- 0.003 inches.The difference observed is greater than the tolerance.Inspection confirmed a bulge at the 10ml location on the syringes.This bulge is most likely the cause of the reported condition of the complaint.However, the investigation did not identify the root cause of the bulge.Nothing was found that could have caused a bulge in syringes.A thorough investigation of the production was performed, including examination of the autoclave documents.The investigation demonstrated that no related issue was recorded throughout all manufacturing and control processes.The manufacturing records were reviewed and nothing out of the ordinary occurred during the overall process for this lot.A review specifically for plunger and syringe defects was also performed in the manufacturing records and nothing out of the ordinary has occurred.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.Also, each lot is released based on an aql sampling.As per the final quality inspection report of this lot, all specification criteria were conforming.The bulge is most likely the cause of the reported condition of the compliant, but the root cause of this bulge could not be identified at this time.No corrective or preventive action will be initiated for the moment.This complaint will be used for trending and qa purposes.

• Brand Name: 12CC SALINE SYRINGE (10CC)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8236561
• MDR Text Key: 132788009
• Report Number: 1282497-2019-08227
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 18D0814
• Date Manufacturer Received: 01/07/2019
• Patient Sequence Number: 1