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

Model Number 8881570121

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/15/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the syringe tip broke off inside the catheters.

Manufacturer Narrative

Submission date: (b)(4) 2018 an investigation was performed for the reported customer complaint: ¿the customer reported that the syringe tip broke off inside the catheters.¿ the actual device was not returned for evaluation.Samples were provided from the customer.These samples were sealed, sterile product.No fault could be found with these samples.Without the device or a representative sample being provided, a more comprehensive investigation could not be performed.The reported issue could not be replicated.A review of the device history records (dhr) for reported lot number 17h0954 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.The reported customer complaint is not confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for 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: 7274609
• MDR Text Key: 100433012
• Report Number: 2182208-2018-00307
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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
• Device Operator: Other
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 17H0954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1