MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, (b)(6) 2011 was used based on age of patient.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd safetyglide¿ needle the needle was clogged.This is mdr 1 of 2 for the original awareness date.There was no report of patient impact.The following information was provided by the initial reporter: not allowing medication to be administered.Will not flow through.Additional information received on 29-aug-2023.Are you able to provide the date of incident? (b)(6) 2023 are the most recent- we have the needle from today.Are you able to confirm the quantity of defective needle? the needle appeared to be normal in size, shape and un tampered with.Is there any patient involvement? if yes, what was the patient outcome? yes,.Patients had to be stuck again to administer medication.The last one was before the injection happened and the needle was changed.What was the medication used? (b)(6) 2023 tdap to a 12 year old, (b)(6) 2023 lidocaine 2% for a 89 year old, lidocaine and kenalog mix for a 90 year old.What type of procedure was being performed? immunization and joint injection respectively.Was the procedure completed as planned? yes, even though the 12 year old was not a happy camper.Was there any visible blockage? none, needle appeared to be normal in size and shape and did not appear to be tampered with.It just would not push the injectable through.Is sample available to be return for investigation? if no, can a photo be provided? yes.We have 4 boxes of needles that we are afraid to use because we do not want to have to stick a patient twice.
Event or Problem Description
It was reported while using bd safetyglide¿ needle the needle was clogged.This is mdr 1 of 2 for the original awareness date.There was no report of patient impact.The following information was provided by the initial reporter: not allowing medication to be administered.Will not flow through.Additional information received on 29-aug-2023 1.Are you able to provide the date of incident? (b)(6) 2023 are the most recent- we have the needle from today.2.Are you able to confirm the quantity of defective needle? the needle appeared to be normal in size, shape and un tampered with.3.Is there any patient involvement? if yes, what was the patient outcome? yes,.Patients had to be stuck again to administer medication.The last one was before the injection happened and the needle was changed.4.What was the medication used? (b)(6) 2023 tdap to a 12 year old, (b)(6) 2023 lidocaine 2% for a 89 year old, lidocaine and kenalog mix for a 90 year old.5.What type of procedure was being performed? immunization and joint injection respectively.6.Was the procedure completed as planned? yes, even though the 12 year old was not a happy camper.7.Was there any visible blockage? none, needle appeared to be normal in size and shape and did not appear to be tampered with.It just would not push the injectable through.8.Is sample available to be return for investigation? if no, can a photo be provided? yes.We have 4 boxes of needles that we are afraid to use because we do not want to have to stick a patient twice.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-sep-2023.Investigation summary: two hundred and forty samples were provided to our quality team for investigation.Eighty samples were randomly selected for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.Seventy-seven samples expelled the solution with a normal flow.Three samples did not expel the solution; these needles are clogged.Furthermore, a device history record review was completed for provided batch number 2188470.According to the sampling plan applied for product performance, this batch was accepted and released without defects being noted during the final assembly or visual inspections.Additional device histories were reviewed for each lot of needles used in the manufacturing of this batch.During the history review, one lot was identified as having suffered from clogged needles due to silicone.It could be possible some samples are escapes from the incident that occurred during production.Corrective and preventative actions have been implemented.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the investigation and with the sample analysis the symptom reported is confirmed.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17736622
• Report Number: 1213809-2023-00996
• Device Sequence Number: 6059875
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: (01)10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: Other
• Device Catalogue Number: 306616
• Device Lot Number: 2188470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Unknown