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

Model Number	305900
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a needle clog occurred during use with a needle sftygld 22x1-1/2 rb.The following information was provided by the initial reporter, "while rn was administering an im medication using the 22g safety glide needle when, half way through pushing the med, the infusion stopped.The rn retracted the needle slightly and tried a bit more force on the plunger to no avail.Once rn removed needle from patient, rn was still unable to advance the medication through the needle.The rn switched needles and was able to administer the remainder of the dose, although it required two injections to do so.Uncertain as to whether this was due to needle malfunction or "clot" in the medication (betamethasone) being administered.".
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that a needle clog occurred during use with a needle sftygld 22x1-1/2 rb.The following information was provided by the initial reporter, "while rn was administering an im medication using the 22g safety glide needle when, half way through pushing the med, the infusion stopped.The rn retracted the needle slightly and tried a bit more force on the plunger to no avail.Once rn removed needle from patient, rn was still unable to advance the medication through the needle.The rn switched needles and was able to administer the remainder of the dose, although it required two injections to do so.Uncertain as to whether this was due to needle malfunction or "clot" in the medication (betamethasone) being administered.".

• 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: 9428430
• Report Number: 1213809-2019-01228
• Device Sequence Number: 504000
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 8324528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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