MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 304432

Device Problem Complete Blockage (1094)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 200422.Medical device expiration date: 2025-03-31.Device manufacture date: 2020-04-29.Medical device lot #: 200904.Medical device expiration date: 2025-03-31.Device manufacture date: 2020-04-29.Investigation summary: a device history record review was completed for provided material number 304432 and potential lot numbers 200422 and 200904.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples for each potential lot number reported were obtained for evaluation by our quality engineer team.The needle samples were assembled with a discardit 2ml syringe and liquid was found to move through the cannula normally with no signs of clogging or occlusion.Based on the provided feedback, we understand that an issue of clogged needle took place at the user location.Inspections for occlusion are also completed after assembly within the manufacturing facility.In certain circumstances, the drug used can become deposited within the cannula, causing the needle to block due to crystallization.Occlusion is most likely to occur if the drug remains in the needle for an extended period of time.At this time, an exact cause cannot be determined for this reported incident.If this event were to reoccur, we would appreciate the opportunity to complete a thorough analysis of the affected product sample.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported that 120,000 bd microlance hypodermic needle 21g x 1.5" green were clogged.The following information was provided by the initial reporter: the suspension didn't flow through the needle.Green canula not permeable.Pharmacist forwarded a report from the nurse, saying the injection was stopped so they couldn't inject the suspension, the suspension didn't go through.

• Brand Name: BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16075084
• MDR Text Key: 308245606
• Report Number: 3002682307-2022-00353
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

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
• Device Operator: Other
• Device Catalogue Number: 304432
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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