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

Model Number	1186000777
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
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.
Event or Problem Description
The customer reported that shortly after change of shift, it was noted that the lipids line was wet.Tracing back up to the spot where the syringe was screwed into the line's hub there was a large amount of leakage.The end of the syringe was broken.Lipids were stopped and disconnected from the patient and the nurse practitioner was made aware.The pharmacy was contacted and they stated that it was all prepared under a hood to maintain sterility so the whole set up (tpn, total parenteral nutrition, included) would need to be redone.The nurse practitioner was made aware and stated that the patient could go without lipids for the night.Additional information was received from the customer stated that there was no impact to the patient and no intervention needed for the patient other than replacing the medication.
Additional Manufacturer Narrative
H3 device evaluation: without a known lot number, the device history record (dhr) cannot be reviewed.The manufacturing site received one unsealed packaged sample for evaluation.A complete investigation was performed.The sample was received with tubing included in the bag which is not manufactured at this manufacturing site.The syringe sample was received with a sticky substance adhered to the outside of the syringe, most likely from a label applied by the end user.Visual inspection to the quality inspection standard (qis) was conducted.A broken off luer tip was identified on the syringe sample.Visual inspection of the tubing identified the broken tip inside the connector of the tubing.The root cause could not be determined from the evaluation.Although the reported issue of a broken tip is confirmed, the root cause cannot certainly be identified to be manufacturing-related.There are sensors at the printer station for verification of a missing luer tip and sensors that verify the syringes after they are ejected.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel through a quality alert for heightened awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11412773
• Report Number: 1915484-2021-01214
• Device Sequence Number: 14447149
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 1186000777
• Device Catalogue Number: 1186000777
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Weight: 3