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	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4.The initial reporter also notified the fda on 05jul2023.Medwatch report # mw5120481.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 that the bd safetyglide¿ needle was clogged.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the needle was occluded, medication would not draw up.Patient to receive proquad vaccine and after stick the medication was not able to be administered as the needle was occluded.Patient required a second stick.The medication is not drawn up with this needle.Needle is only used for administration.Safety hypodermic needles glide 25g 1"- lot 2188472.This needle was discarded but have samples from this lot number if requested.This is the second occurrence with this specific lot number at two different clinics.Was there any patient involvement on the first occurrence? no.Was there any patient impact on the first occurrence? no.What was the patient outcome for the first occurrence? no.What medication was used on the first occurrence? no.".
Event or Problem Description
It was reported that the bd safetyglide¿ needle was clogged.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the needle was occluded, medication would not draw up.Patient to receive proquad vaccine and after stick the medication was not able to be administered as the needle was occluded.Patient required a second stick.The medication is not drawn up with this needle.Needle is only used for administration.Safety hypodermic needles glide 25g 1"- lot 2188472 this needle was discarded but have samples from this lot number if requested.This is the second occurrence with this specific lot number at two different clinics.Was there any patient involvement on the first occurrence? no.Was there any patient impact on the first occurrence? no.What was the patient outcome for the first occurrence?no.What medication was used on the first occurrence?no.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or photos received by our quality team for evaluation.Furthermore, a device history record review was completed for provided batch number 2188472.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, two lots were 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 17768040
• Report Number: 1213809-2023-01012
• Device Sequence Number: 7165834
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: 10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/30/2023

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: 2188472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown