MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE CATHETER TIP; SYRINGE, PISTON

Model Number 1186000444

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported there is a loss of suction and medication is leaking out of the syringes.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Physical samples were not received for the investigation, but three photos were provided.A limited investigation was performed by visually analyzing the photos.Two of the three images are of the soft packaging showing product code 1186000444 and lot number 720624x.The other photo shows a plunger and rubber tip assembly which has been removed from the barrel of the syringe.The barrel is not visible in this image.Although it is difficult to see with certainty, it appears as though the rubber tip may be either malformed or damaged.The rubber tip seems to be fully seated onto the plunger tip and the plunger does not appear to be broken.Without a physical sample being returned for evaluation, we are unable to visually confirm a specific issue, complete a physical analysis of the syringe to confirm the functionality, or determine a definitive root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A quality alert will be placed to create further awareness of the reported condition.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 60ML SYRINGE CATHETER TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9461226
• MDR Text Key: 173087128
• Report Number: 1915484-2019-01109
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1186000444
• Device Catalogue Number: 1186000444
• Device Lot Number: 720624X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Patient Sequence Number: 1