MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; SAFETY ENGINEERED HYPODERMIC NEEDLE

Catalog Number 305269

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd integra¿ syringe with detachable needle felt slippery before use.Customer noted they could see droplets inside the syringe.No reports of serious injury noted.

Manufacturer Narrative

Additional information: samples from three lots were returned for analysis.D.4.Device lot #: 7001876.D.4.Device expiration date: 12/31/2021.H.4.Device manufacture date :01/01/2017.D.4.Device lot #: 6201981.D.4.Device expiration date: 12/31/2021.H.4.Device manufacture date : 01/01/2017.D.4.Device lot #: 6004730.D.4.Device expiration date: 12/31/2021.H.4.Device manufacture date : 01/04/2016.H.6.Investigation results: sample evaluation: one shelf carton received by bd canaan containing multiple packaged integra syringes with needle.See below for details.87 sealed and 1 open packaged syringes confirmed to be from batch # 7001876 (p/n 305269) one sample bag containing 20 sealed and 2 open packaged syringes confirmed to be from batch # 6201981 (p/n 305269).The sample bag also contained one open packaged syringe confirmed to be from batch #6004730 (p/n 305269).The samples were visually evaluated.20 syringes were randomly selected to perform visual evaluation of assembled syringes.No visual defects were observed.The droplets observed inside the syringes is silicone used in the manufacturing process.The small amount observed is normal and expected amount for this product per product specification.Dhr review for batch 7001876 (p/n 305269): manufacturing dates: 01/27/2017 to 01/29/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7001876 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 6201981 (p/n 305269): manufacturing dates: 08/14/2016 to 08/23/2016.Batch quantity was (b)(4).Visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6201981 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 6004730 (p/n 305269): manufacturing date: 01/09/2016 to 01/18/2016.Batch quantity was (b)(4) all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6004730 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Based on the sample evaluation: unconfirmed: bd canaan was not able to duplicate or confirm the customer's indicated failure.Root cause and capa not required as no defects were confirmed.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SAFETY ENGINEERED HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7364559
• MDR Text Key: 103428905
• Report Number: 1213809-2018-00195
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: 30382903052692
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 305269
• Device Lot Number: 7001876
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other