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

Catalog Number 305270

Device Problems Material Separation (1562); Inadequacy of Device Shape and/or Size (1583); Volume Accuracy Problem (1675)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Fda notified: the initial reporter also notified the fda on 07/09/2018 medwatch # mw5078343.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 Description

It was reported that bd integra¿ syringe with detachable needles had stopper angularity or irregular plunger size.This condition resulted in volumetric inaccuracy.It was also reported that on one syringe the rubber stopper end had separated from the plunger rod.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that bd integra¿ syringe with detachable needles had stopper angularity or irregular plunger size.This condition resulted in volumetric inaccuracy.It was also reported that on one syringe the rubber stopper end had separated from the plunger rod.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, 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 manufacture: no.Nvestigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Dhr review showed release date: 02/12/2018.Released quantity was (b)(4).Stopper angularity defects were found during the manufacture of this batch.Adjustments were made and product was requalified per applicable aql before production resumed.Batch 8002915 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.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.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7781208
• MDR Text Key: 117270997
• Report Number: 1213809-2018-00521
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 305270
• Device Lot Number: 8002915
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other