MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305785
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Pma/510(k)#: k980987(syringe); k161170 (needle).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that the syringe 5ml ll w/needle 22x1-1/2in rb experienced difficulty engaging the safety mechanism during use.The following information was provided by the initial reporter: white cap is loose.When the pink cover is squatting, the white cap is directly released, and the caregiver almost pinches.
Event or Problem Description
It was reported that the syringe 5ml ll w/needle 22x1-1/2in rb experienced difficulty engaging the safety mechanism during use.The following information was provided by the initial reporter: white cap is loose.When the pink cover is squatting, the white cap is directly released, and the caregiver almost pinches.
Additional Manufacturer Narrative
H.6.Investigation summary: a lot number could not be connected to the device identified in the complaint, so bd investigators could not conduct a device history review for this event.Additionally, a sample was not submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.H3 other text : see section h.10.

• Brand Name: SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8951688
• Report Number: 2243072-2019-01871
• Device Sequence Number: 16666126
• Product Code: FMI
• UDI-Device Identifier: 30382903057857
• UDI-Public: 30382903057857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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 Catalogue Number: 305785
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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