MAUDE Adverse Event Report: COVIDIEN LIFSHLD 250-E 18X1 RBLT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881202017
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
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 through medwatch that the rn complained that the needles were leaving tiny pieces of rubber in the syringe.The rn stated that she was double checking her medication when she noticed a tiny piece of rubber in the medication.The rn also noticed that the needles were flat, not beveled, causing a punch out of the rubber seal each time they were used.The punch out logged into the needle and gets sucked into the syringe with the medication.The rn immediately went to all floors and advised the supervisor to remove these needles from their stock.The staff were advised to search for any place where blunt needles are used to make sure that none are missed.The stock room was advised to not restock this product.The next shift was advised of the issue and all staff were told not to restock this item if any more were found.There was no harm to any patient.
Additional Manufacturer Narrative
The device history record (dhr) review could not be reviewed as no lot information provided.There were no samples returned for investigation.As no information of the reported condition could be identified within the production documentation the root cause could not be identified.As part of continuous improvements, a formal investigation has been opened to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa tracking and trending purposes.

• Brand Name: LIFSHLD 250-E 18X1 RBLT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11685359
• Report Number: 1017768-2021-00923
• Device Sequence Number: 2935439
• Product Code: FMI
• UDI-Device Identifier: 10884521082892
• UDI-Public: 10884521082892
• 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: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 8881202017
• Device Catalogue Number: 8881202017
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1