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

Model Number	305900
Medical Device Problem Codes	Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle did not retract and medication leaked out of needle during use with a bd safetyglide¿ needle.The following information was provided by the initial reporter: it was reported the retractable spring does not retract.It was also reported that medication leaked out of the needle.Patient was involved but no harm or adverse effects.
Event or Problem Description
It was reported that the needle did not retract and medication leaked out of needle during use with a bd safetyglide¿ needle.The following information was provided by the initial reporter: it was reported the retractable spring does not retract.It was also reported that medication leaked out of the needle.Patient was involved but no harm or adverse effects.
Additional Manufacturer Narrative
H.6.Investigation: a total of 12 sealed packaged safetyglide needles from multiple batches were received, all were p/n 305900.4 packages were from the reported batch 8212561, 1 package was from batch #8285702, 7 packages were from batch 9316337.Since the described alleged defect is not applicable to this product, the samples could not be evaluated.It was also unknown for what purpose the samples for the two additional non-reported batches were sent.The described alleged defect of issues with a ¿retractable spring¿ and needle ¿not retracting at all¿ are not applicable to this product.The safetyglide needle product does not have a retractable spring and the needle in this product does not retract per specification.Since no clarification was received regarding the alleged failure, no investigation can be performed on the returned samples.The reported defect was not identified in the samples 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.

• Brand Name: BD SAFETYGLIDE NEEDLE
• 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: 9727857
• Report Number: 1213809-2020-00115
• Device Sequence Number: 3069098
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 04/02/2020

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: 07/03/2023
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 8212561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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