MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 21X1 RB; PISTON SYRINGE

Model Number	309624
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) has been used as a placeholder based on the reported phone area code.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Dhr review: release date: 3/22/2016.Released quantity was 352,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6061564 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.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: since no samples displaying the reported condition were received a potential root cause could not be defined.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.
Event or Problem Description
It was reported that the syringe 1ml s/t w/ndl 21x1 rb needle pulled out of the hub before use.The following information was provided by the initial reporter: "consumer stated he currently uses the 1 ml tuberculin syringe and when removing the needle cap the needle comes off with it.Stated the needle cap seems to be on ultra tight and the needle is "snug" but not on tight.".

• Brand Name: SYRINGE 1ML S/T W/NDL 21X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10659744
• Report Number: 1213809-2020-00704
• Device Sequence Number: 11500584
• Product Code: FMF
• UDI-Device Identifier: 30382903096245
• UDI-Public: 30382903096245
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 309624
• Device Catalogue Number: 309624
• Device Lot Number: 6061564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/09/2020
• 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