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

Model Number	305111
Medical Device Problem Codes	Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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 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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd implemented a thorough investigation following our corrective preventative action protocol.This was opened for a trend in reports of ¿needle clogged / blocked¿, ¿aspirate / draw (cannot / difficult)¿, and ¿needle bent¿.All three of these issues have the same net effect: temporary interruption of flow of insulin into the reservoir.Based on the investigation, these issues appear to be related to the use case which involves drawing insulin from a vial into a syringe and then filling the reservoir of the insulin pump via a small port off the body in an iterative process, utilizing existing / ¿off the shelf¿ products rather than a product designed for this use.Bd products are designed to be single use, and because this is an "off the shelf" product, bd specifications do not take into account any requirements specific to the tandem use case.The investigation concludes the complaints are related to the use case and not due to a product nonconformance.
Event or Problem Description
It was reported that 5 needle 26x1/2 rb had clogged needles and foreign matter during use.The following was reported by the initial reporter: "caller reported needles getting plugged with white rubber when getting ready to refill syringe with insulin.To resolve issue caller changed needle.".

• 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: 11936804
• Report Number: 2243072-2021-01590
• Device Sequence Number: 11103289
• 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): 05/24/2021

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: 05/07/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR