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

Catalog Number 305916

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 15 bd safetyglide¿ needles were blocked during use.The following information was provided by the initial reporter: "the needle is occluded, and they can't push the medicine through.".

Event Description

It was reported that 15 bd safetyglide¿ needles from lot 2025238, 1 needle each from lots 2025237 and 2195356 were blocked during use.The following information was provided by the initial reporter: "the needle is occluded, and they can't push the medicine through.".

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that 15 bd safetyglide¿ needles from lot 2025238, 1 needle each from lots 2025237 and 2195356 were blocked during use.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2025238 d.4.Medical device expiration date: 31-dec-2026 h.4.Device manufacture date: 25-jan-2022 d.4.Medical device lot #: 2025237 d.4.Medical device expiration date: 31-dec-2026 h.4.Device manufacture date: 25-jan-2022 d.4.Medical device lot #: 2195356 d.4.Medical device expiration date: 30-jun-2027.H.4.Device manufacture date: 14-jul-2022 h6: investigation summary it was reported the needle was occluded.To aid in the investigation, twenty-nine samples were received for evaluation by our quality team.One sample came in a sealed packaging blister with lot 2195356.The remaining twenty-eight samples came with no packaging blisters.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.The sample in the sealed packaging blister expelled the solution with a normal flow.From the additional twenty-eight samples.Twenty-six samples expelled the solution with a normal flow and two did not; these two needles are clogged.A device history record review was completed for provided material number 305916, lot numbers 2025237, 2025238 and 2195356.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lots 2025237, 2025238 and 2195356 were inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Additional device histories were reviewed for each batch of needles used in the manufacturing of this batch.During the history review, additional 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.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 returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16057280
• MDR Text Key: 308477639
• Report Number: 1213809-2022-01316
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305916
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1