MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE W/O SAFETY; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305156
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples or photos were provided by the customer for investigation.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of needle clogged / blocked for lot #8361924 item #305156.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Root cause description: while a definitive root cause could not be determined, foreign material (fm) can be introduced to the fluid path during the manufacturing process which could cause the needle to become clogged.All product is automatically checked for clogged needles during the production process.Rationale: based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.Therefore, no corrective or preventative actions are proposed in the scope of this complaint.
Event or Problem Description
It was reported that bd¿ hypodermic precisionglide¿ needle w/o safety was clogged.This occurred on 4 occasions during use.The following information was provided by the initial reporter: material no.305156, batch no.8361924.It was reported that needle was unable to draw up, needle clogged/blocked.Per email: ordered 7 boxes and they had to pull the box they were not getting any flow into the needle when pulling the injectable.

• Brand Name: BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE W/O SAFETY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8749483
• Report Number: 1911916-2019-00646
• Device Sequence Number: 13870201
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 305156
• Device Lot Number: 8361924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Other