MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 26X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305111
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.".
Event or Problem Description
It was reported that a needle 26x1/2 rb had a loose needle during use.The following was reported by the initial reporter: "it was reported that the needle went into the syringe when pushing it into the cartridge, fill resistance was encountered, event description per attached email states: (b)(4)."caller reported patient states the needle went into the syinge when number of occurrences -1.Did the caller insert the needle into the cartridge and encounter fill resistance? - no.Product with issue - bd 26 g, 1/2"" needle, pn 305111.Product lot # - unavailable.Did issue cause any injury? - no.Did customer require medical intervention? - no.Is product available for return to bd? ¿ no.Was caller able to fill a cartridge with insulin? ¿ no.Resolution ¿ patient change syringes and was able to fill cartridge.Created by (customer) at 3/22/2021 6:41:23 pm.Subject: cts note.Cts to clarify syringe intake note.Caller reported the needle went into the syringe when pushing it into the cartridge.".

• Brand Name: NEEDLE 26X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11701756
• Report Number: 2243072-2021-01213
• Device Sequence Number: 14336334
• Product Code: FMI
• UDI-Device Identifier: 30382903051114
• UDI-Public: 30382903051114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 305111
• Device Catalogue Number: 305111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR