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

Model Number	305785
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that syringe 5ml ll w/needle 22x1-1/2in rb barrel was damaged.This was discovered before use.The following information was provided by the initial reporter: empty needle barrel with broken laceration.
Event or Problem Description
It was reported that syringe 5ml ll w/needle 22x1-1/2in rb barrel was damaged.This was discovered before use.The following information was provided by the initial reporter: empty needle barrel with broken laceration.
Additional Manufacturer Narrative
H.6.Investigation: to aid in the investigation of this incident, two picture samples were received for evaluation by our quality engineer team.Through examination of the picture samples, the reported defect was clearly observed, however, the exact cause for the observed damage could not be identified.As a lot number was unknown for this incident, a review of the production history could not be completed.This product is no longer manufactured at the manufacturing facility that investigated this defect; however, our quality team will continue to monitor the production process for signs of similar defects or emerging trends.H3 other text : see 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: 10171336
• Report Number: 2243072-2020-00927
• Device Sequence Number: 14261397
• Product Code: FMI
• UDI-Device Identifier: 30382903057857
• UDI-Public: 30382903057857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• 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): 07/06/2020

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 Model Number: 305785
• Device Catalogue Number: 305785
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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