MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 25X5/8 RB TW; PISTON SYRINGE

Model Number	305310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the needle integra 25x5/8 rb tw experienced leakage prior to use.The following information was provided by the initial reporter: material no.: 305310, batch no.: 7263635.Per email pir: syringe is leaking fluid when correct needle is placed on.
Additional Manufacturer Narrative
Investigation: one sample was received.It came in the sealed packaging blister.Visual inspection under the microscope -30x- was performed, no damage, deformation or any other defect was observed.Root cause could not be verified therefore failure mode was undetermined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that the needle integra 25x5/8 rb tw experienced leakage prior to use.The following information was provided by the initial reporter: material no.: 305310 batch no.: 7263635.Per email pir: syringe is leaking fluid when correct needle is placed on.

• Brand Name: NEEDLE INTEGRA 25X5/8 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9490713
• Report Number: 1911916-2019-01312
• Device Sequence Number: 19268200
• Product Code: MEG
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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): 12/27/2019

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 Expiration Date: 08/31/2022
• Device Model Number: 305310
• Device Catalogue Number: 305310
• Device Lot Number: 7263635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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