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

Catalog Number 309571

Device Problems Entrapment of Device (1212); Retraction Problem (1536)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2018

Event Type  malfunction  

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.Device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Dhr review for batch 7235628 (p/n 305270): manufacturing dates: 09/21/2017 to 09/23/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7235628 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Root cause description: root cause and capa not required as no defects were confirmed.

Event Description

It was reported that during use a bd integra¿ syringe with detachable needle malfunctioned as the needle retraction failed "and remains inside the patient.The patient received an injection on (b)(6) 2018 at the (b)(6) health center and was instructed to go to the emergency room.The healthcare staff stated the emergency room referred the patient to an orthopedic surgeon to get the needle removed.The healthcare staff does not know if/what treatment the patient received at the emergency room.No further information is available in regards to what medical intervention was needed.

Manufacturer Narrative

H.6.Additional information was received for the medical device lot number(s), category number (s), manufacturing/expiration date(s), manufacturing location.The following field(s) have been updated: d.1.Medical device brand name: bd¿ luer-lok with needled.2.Medical device type:fmf, d.3.Medical device manufacturer: cannan, d.4.Common device name: piston syringe, d.4.Medical device lot #:7093501, d.4.Medical device cat #: 309571, d.4.Udi: 30382903095712, d.4.Medical device expiration date: 03/31/2022.G.1.Manufacturing location: cannan, g.5.510k: k980987, h.4.Device manufacture date: 2017-04-03.The medical device manufacturer location for this device is canaan, manufacturer site no.1213809.The following fields have been updated to reflect the updated manufacturing site.D.3.Medical device manufacturer: becton dickinson medical system, g.1.Manufacturing location: becton dickinson medical systems.

• Brand Name: BD¿ LUER-LOK WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7558723
• MDR Text Key: 111301526
• Report Number: 1213809-2018-00351
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 309571
• Device Lot Number: 7093501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention