MAUDE Adverse Event Report: COVIDIEN MONOJECT; SALINE, VASCULAR ACCESS FLUSH

Model Number 8881570121

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received at the manufacturing site 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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports prior to use, the clinicians stated that the saline smelled like alcohol.

Manufacturer Narrative

Submission date: (b)(4) 2018 an investigation was performed for the reported customer complaint: ¿the customer reports prior to use, the clinicians stated that the saline smelled like alcohol.¿ a review of the device history records (dhrs) for reported lot numbers 18a0124, 18b0334 and 18b0224 indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.During the manufacturing of the syringe assemblies, syringes are visually inspected and physically tested.Control mechanisms are in place to prevent the occurrence and acceptance of damaged syringes during the syringe molding, assembly and packaging processes.These mechanisms include, but are not limited to: material verification/certification processes, periodic audits, dimensional specifications, machine maintenance requirements, and personnel training and certification.A lot cannot be released unless it passes all visual and physical testing requirements.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.Testing for this component during production includes the verification for a solution not clear or colorless.The lots also met all chemical and microbiological testing.No adverse conditions, special circumstances, or events were documented that may have led to the re ported event.Samples were returned for the complaint lots.Four (4) syringes for lot no.18a0124, three (3) syringes for lot no.18b0334 and three (3) syringes for lot no.18b0224.Due to the limited quantity of samples returned, a complete testing could not be performed (identification, iron and heavy metals tests could not be performed).The following tests were done on a pool of the returned samples for each lot: appearance, odor, ph and assay.For each lot, all tests were found conforming.The odor test was done twice: immediately after transferring the liquid into a beaker and after 15 minutes.The usual characteristic odor of the product (a plastic odor due to the polypropylene syringe) was noted.No abnormalities were observed.The reported alcohol-like odor was most likely to have been mistaken for a strong odor of saline and plastic from the syringes.This characteristic odor of the syringe is inherent to the product due to the components used.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): COVIDIEN; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7519014
• MDR Text Key: 108496175
• Report Number: 2182208-2018-00918
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 18A0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1