MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE INTEGRA 22X1-1/2 RB TW; PISTON SYRINGE

Model Number	305313
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: no root cause can be determined as no samples were received.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the needle integra 22x1-1/2 rb tw leaked during a "long acting deep intramuscular injection", causing an underdose of medication.The following information was provided by the initial reporter: "t2 failures in 7 days, leakage of oil based long acting deep intramuscular injection.This caused reduced medication dosage administration.".

• Brand Name: NEEDLE INTEGRA 22X1-1/2 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11032886
• Report Number: 1213809-2020-00897
• Device Sequence Number: 1308056
• Product Code: MEG
• UDI-Device Identifier: 30382903053132
• UDI-Public: 30382903053132
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 07/31/2023
• Device Model Number: 305313
• Device Catalogue Number: 305313
• Device Lot Number: 8141884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/17/2020
• 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