MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305900
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Root cause description: since no samples displaying the reported condition were received a potential root cause could not be defined.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.
Event or Problem Description
It was reported that 2 needles sftygld 22x1-1/2 rb had a plunger that was difficult to move.The following information was provided by the initial reporter: "it was reported that the administrator experienced resistance when pushing plunger to administer medication from a non bd syringe.The needle was changed to a 22g bd safetyglide needle and a different insertion site was selected and same resistance was met upon pushing down on the plunger.Nurse clinician attempted a third time with a 22g bd safetyglide needle and same resistance was met again.Event description states: incident details: upon administration of sandostatin lar md 20mg intramuscularly to patients right gluteal region, writer met resistance when pushing plunger down to administer medication - needle removed (19gauge x 1.5 inch needle used from sandostatin kit).Writer changed needle and re-attempted injection im in different site of right gluteal region with same resistance met upon pushing plunger down (22gauge x 1.5 inch bd safetyglide needle used).Nurse clinician attempted a third time to left gluteal region with another new 22gauge x 1.5 inch bd safetyglide needle, same resistance met once again.When needle was removed, medication was able to be purged freely with no resistance.Unsure of reason that injections were unsuccessful x 3 attempts.Who was affected? patient".

• Brand Name: NEEDLE SFTYGLD 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10606279
• Report Number: 1213809-2020-00672
• Device Sequence Number: 11060818
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 09/11/2020

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 Expiration Date: 12/31/2024
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 0002408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/30/2020
• 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