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

Catalog Number	305273
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd integra¿ syringe with detachable needle there was an issue with spring failure.When the needle retracted, the spring did not retract into the plunger.Instead, it curled up in the syringe, between the hub and plunger.Could not see the needle in the syringe, or anywhere so the patient was given a x-ray to determine if it was lodged in the patient.It was negative and the needle was found in the plunger of the syringe.
Additional Manufacturer Narrative
No samples from the reported malfunctioning syringe were received.According to the complaint description and clarification from the customer and the sales representative, the product in question performed as designed and as intended.The needle was found in the plunger of the syringe as that is the place it retracts into by design.34 samples in 1 box from batch #7271531 (p/n 305273) were received.All samples were sealed packaged syringes.No visual defects were observed on the returned samples.The representative samples were all tested for needle retraction.All 34 syringes passed their needles retracted correctly.Furthermore, a 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.The integra syringe product in the complaint description functioned as designed by retracting the needle into the barrel.The needle retraction is not a defect, but a feature of the product.The syringe is not intended to be taken apart after activation.Detaching the hub would expose the spring and the metal cutter, which are part of the retraction mechanism.It is unsafe to do so, it would then be difficult and unsafe to reattach the hub, the spring and the barrel and would lead to the condition described in the complaint.No issues found in the returned representative samples.The reported defect was not confirmed and no corrective actions are necessary.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.
Event or Problem Description
It was reported with the use of the bd integra syringe with detachable needle there was an issue with spring failure.When the needle retracted, the spring did not retract into the plunger.Instead, it curled up in the syringe, between the hub and plunger.Could not see the needle in the syringe, or anywhere so the patient was given a x-ray to determine if it was lodged in the patient.It was negative and the needle was found in the plunger of the syringe.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: no.
Event or Problem Description
It was reported with the use of the bd integra syringe with detachable needle there was an issue with spring failure.When the needle retracted, the spring did not retract into the plunger.Instead, it curled up in the syringe, between the hub and plunger.Could not see the needle in the syringe, or anywhere so the patient was given a x-ray to determine if it was lodged in the patient.It was negative and the needle was found in the plunger of the syringe.

• Brand Name: BD INTEGRA¿ SYRINGE WITH 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: 7794931
• Report Number: 1213809-2018-00533
• Device Sequence Number: 16407188
• Product Code: MEG
• UDI-Device Identifier: 00382903052738
• UDI-Public: 00382903052738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2018

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 305273
• Device Lot Number: 7271531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 07/25/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/14/2018
• 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; Required Intervention