MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 26X3/8 IB; PISTON SYRINGE

Model Number	309625
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl 26x3/8 ib had connectivity issues.This was discovered during use.The following information was provided by the initial reporter: material no: 309625 batch no: 9353360.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl 26x3/8 ib had connectivity issues.This was discovered during use.The following information was provided by the initial reporter: material no: 309625, batch no: 9353360.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are required at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.

• Brand Name: SYRINGE 1ML S/T W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10411650
• Report Number: 1213809-2020-00532
• Device Sequence Number: 2939467
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 309625
• Device Catalogue Number: 309625
• Device Lot Number: 9353360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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