MAUDE Adverse Event Report: COVIDIEN LIFSHLD 3ML 18X1 R.BLT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881202033
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported when used to access a vile, the blunt tip cored the orange rubber seal top of the vial.A particle of the orange rubber was found floating in the syringe prior to injection to the patient.
Additional Manufacturer Narrative
Additional information the device history record (dhr) was not performed during this investigation as the lot number provided in the complaint record is an invalid lot number.All dhrs are reviewed and approved by quality prior to release of product.There were no samples received with this complaint, therefore, an examination of the reported condition could not be made.The reported condition is not confirmed.Previous complaints have been issued for a similar event in which the user was utilizing round blunt needles instead of blunt fill needles.For the previous events, an investigation was performed, and the root cause was identified as the cardinal health market website incorrectly recommended (round blunt needle only) as a substitute for the bd blunt fill needle 18g x 1¿ to customers.The cardinal health market provides suggested alternatives for national brand codes, and codes that are showing on backorder.These alternatives are generated through system logic by looking at input description which determines its corresponding category.This is coupled with cardinal health internal data cards that determine if the code is a ¿similar¿, ¿same¿, or ¿equivalent¿ code, based on different data attributes.It was determined that the data card for this subcategory was correct and distinguished between a blunt cannula and a blunt fill cannula not allowing these two codes to provide crossed references.During the investigation, it was determined that the bd item code had an incorrect input description.The input description was ¿needle blunt 18g x 1in¿, which led this code to be identified as blunt cannula rather than a blunt fill cannula.Since this code was identified as a blunt cannula, it was showing up as an available cross.The incorrect product has been removed from the database.The investigation pertains to the item code in which the previous complaints were issued.This complaint pertains to the same failure, except the item code is a syringe combo.Based on this analysis, this is the root cause of the failure.An assessment is being done to determine if further action is required based on the investigation results identified through this complaint.A corrective and preventative action (capa) was issued to further investigate the failure and implement corrective/preventive actions.This complaint will be used for tracking and trending purposes.

• Brand Name: LIFSHLD 3ML 18X1 R.BLT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 12258448
• Report Number: 1017768-2021-00966
• Device Sequence Number: 11541218
• Product Code: FMI
• UDI-Device Identifier: 10884521082908
• UDI-Public: 10884521082908
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: Health Professional
• Device Model Number: 8881202033
• Device Catalogue Number: 8881202033
• Device Lot Number: 817033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1