MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number	309578
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7122642.Medical device expiration date: 04/30/2022.Device manufacture date: 05/02/2017.Medical device lot #: 7156968.Medical device expiration date: 05/31/2022.Device manufacture date: 06/05/2017.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 bd luer-lok¿ syringe with precisionglide¿ detachable needle leaked radioactive fluid down the side of the barrel through a crack.There was no reports of exposure or serious injury.No medical intervention noted.
Additional Manufacturer Narrative
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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Dhr review for batch 7156968 (p/n 309578): manufacturing dates: 06/26/2017 to 06/27/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7156968 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7122642 (p/n 309578): manufacturing dates:05/16/2017 to 05/20/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7122642 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7329890
• Report Number: 1213809-2018-00116
• Device Sequence Number: 49238
• Product Code: FMF
• UDI-Device Identifier: 00382903095780
• UDI-Public: 00382903095780
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 309578
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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