MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML LL; PISTON SYRINGE

Catalog Number	305283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no: 305283 batch no: unknown.(provided 73349676cav05).It was reported that during use of the syringe integra 3ml ll the syringe was leaking around the luer wasting the vaccine.The following information was provided by the initial reporter: we received the attached concern regarding 3 cases 305283 syringes which are reportedly leaking around the luer.I am waiting for the customer to confirm the lot # as the one they have provided does not appear valid.Fyi only for now, i will updated you as soon as received.
Additional Manufacturer Narrative
Investigation summary: one photo of a loose 3ml integra syringe was received and evaluated.It was observed there was a blue circle in the photo that appeared to display clear liquid droplets.The leakage defect was unconfirmed.A physical sample is required for a more thorough evaluation and potential root cause determination.Potential root cause for the leakage at luer defect could not be determined based on the photo provided.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
Material no: 305283 batch no: unknown (provided 73349676cav05) it was reported that during use of the syringe integra 3ml ll the syringe was leaking around the luer wasting the vaccine.The following information was provided by the initial reporter: we received the attached concern regarding 3 cases 305283 syringes which are reportedly leaking around the luer.I am waiting for the customer to confirm the lot # as the one they have provided does not appear valid.Fyi only for now, i will updated you as soon as received.

• Brand Name: SYRINGE INTEGRA 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9385137
• Report Number: 1213809-2019-01188
• Device Sequence Number: 3012346
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 12/31/2019

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: 305283
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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