MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180600777
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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 that the syringe was losing suction and leaking air into the tube.They had to redraw the sample, there was no harm to the patient.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot no.902816x confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received six samples in sealed packages along with a butterfly connector with this customer report.A complete investigation was performed.A visual inspection according to the quality inspection standard was conducted.The lot number on the samples provided did not match the lot number as reported with the initial customer report.The lot number on the samples provided indicate the product to be manufactured from lot number 903530x.There were no visual anomalies identified.A leak test was performed on all six syringe samples and there were no signs of leaking.A root cause could not be determined based on the investigation findings.Per procedure, complaint trends are evaluated during the monthly meeting to determine if a corrective/preventative action (capa) is warranted.At this time, there is no trending or information that would trigger the need to initiate a capa.

• Brand Name: 6ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8846236
• Report Number: 1915484-2019-01071
• Device Sequence Number: 16784806
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/03/2019

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: 1180600777
• Device Catalogue Number: 1180600777
• Device Lot Number: 914099X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1