MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180300777
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the devices are cracked.No patient injuries or adverse events.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) could not be performed as no lot number was available.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.A search of our complaint database could not be performed as no lot number was able to be identified.There were no samples received for evaluation, but pictures were submitted.The pictures were visually reviewed and showed unused, opened devices.The pictures submitted with this complaint confirm the reported issue.The most likely cause of the failure is due to misloading of the barrel leading to barrel stress, causing cracking.Based on the pictures provided, this is potentially the issue as no other damage is noted.No corrective and preventative action (capa) is warranted at this time as there is no adverse trend to the failure reported.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11877627
• Report Number: 1017768-2021-00944
• Device Sequence Number: 11037798
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 1180300777
• Device Catalogue Number: 1180300777
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/09/2021
• Patient Sequence Number: 1