MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEEDLE,25GX1.5",REG,BEVEL

Catalog Number	SYR100257Z
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported; "the nurses have been using this size for a certain injection and have had the issue of clogging up so they are unable to push the medication through.This has caused the nursing to do another needle stick in order to have the injection completed." email received by facility representative, (b)(6), with additional information in regards to this reported incident.Reporter confirms seven (7) total separate incidents.Specific dates and patient information not provided.Reporter states, medication attempted to be given to each patient in each incident; kenalog, bupivacaine, and rocephin via an intra-muscular (im) injection and joint injections.Reporter states, "we have used 25g (gauge) for each of these medications for years without issues." reporter indicated the following series of event for each incident, "medication drawn up, injected patient with needle, unable to push medication through needle, needle withdrawn, replaced needle and second injection was given.Each time a patient was stuck a second time.Replaced needle with another 25g or used a 26g or we also used a 23g." reporter states, "patient had no lasting effects." reporter confirms samples from the same lot and gauge have been returned for evaluation (investigation results below).Due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.Investigation report reads as follows: on (b)(6) 2021 ((b)(4))."we received 1bx, syr100257z standard hypodermic needles in new condition.The complaint was not confirmed.We randomly selected 20 samples to perform a visual inspection and functional testing.We saw no indications of any physical defects that would prevent the samples from working properly.After requesting additional information from the account, we were informed that they were using these needles alongside either a 3ml or 5ml bd luer-lok tip syringe.Next, we functionally tested each sample by connecting 10 each to a 3ml syringe (3ml- bd309657z) and 10 each to a 5ml syringe (5ml- bd309646z), and drawing up fluids using a small cup of water.The syringes were filed with water to different measurement levels and we saw no indications of clogging within the needles or needing to use excessive force in order to dispense the liquid.During testing, we did not observe any blockage in the needles; the fluid (water) was able to be flushed through each needle without any occlusion.Each sample dispensed the liquid smoothly and worked properly.The samples worked as intended.".
Event or Problem Description
It was reported; "the nurses have been using this size for a certain injection and have had the issue of clogging up so they are unable to push the med through.This has caused the nursing to do another needle stick in order to have the injection completed.".

• Common Device Name: NEEDLE,25GX1.5",REG,BEVEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12360795
• Report Number: 1417592-2021-00134
• Device Sequence Number: 14300781
• Product Code: FMI
• UDI-Device Identifier: 10080196305575
• UDI-Public: 10080196305575
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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 Catalogue Number: SYR100257Z
• Device Lot Number: 201223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention