MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE W/ LUER-SLIP TIP AND NEEDLE; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 307737

Device Problems Out-Of-Box Failure (2311); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

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 red seal on the bd emerald¿ syringes with luer-slip tip and pre-attached needle(s) were open when they arrived.This was observed before use and there was no report of injury or medical interventions.

Manufacturer Narrative

We have been provided with pictures of the affected samples.Visual inspection of the provided pictures of the samples reveal the presence of the red tape in the film used by the supplier.That confirmed the reported issue.We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine nº2017 (november 7 - 11th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also review the film lot #683356 used, and no issue was found.After the evaluation of the returned pictures of the samples we confirmed that the red tape corresponds to a joint in the reel of film used for primary packaging.This red strip is added by the supplier to facilitate the identification and removal during primary packaging.We have a chromatic vision system, which detects this red tape and stops the primary packaging machine.For the affected samples, this system did not work as expected and the red tape was not removed during manufacturing.We are confident the occurrence of this issue is very low and there should not be any recurrence in the batch in addition to the already observed product.In addition, we have checked the mentioned detection system and have alerted the personnel of the affected area about this issue.The returned pictures of the samples presented the reported issue.We could confirm the reported issue.No - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

• Brand Name: BD EMERALD¿ SYRINGE W/ LUER-SLIP TIP AND NEEDLE
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7367559
• MDR Text Key: 103533259
• Report Number: 3002682307-2018-00070
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 307737
• Device Lot Number: 1711180
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other