MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	305312
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device expiration date: unknown.Device manufacture date: unknown.Lot #: the reported lot # 7235634cav19 was not found for the catalog number.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that leakage occurred at a unspecified time with a bd integra¿ syringe with detachable needle.The following information was provided by the initial reporter, "clinical event information: medication leaking out of device while in use.Patient outcome/consequences: loss of medication / not administered to patient due to fault.".
Event or Problem Description
It was reported that leakage occurred at a unspecified time with a bd integra¿ syringe with detachable needle.The following information was provided by the initial reporter, "clinical event information: medication leaking out of device while in use.Patient outcome/consequences: loss of medication / not administered to patient due to fault.".
Additional Manufacturer Narrative
Investigation: 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.A device history record review could not be performed as lot number was unknown.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8857474
• Report Number: 1213809-2019-00802
• Device Sequence Number: 16829903
• Product Code: MEG
• UDI-Device Identifier: 30382903053125
• UDI-Public: 30382903053125
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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 Catalogue Number: 305312
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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