MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP; HYPODERMIC SYRINGE

Catalog Number 307727

Device Problems Bent (1059); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter fax #: (b)(6).Facility name: (b)(6).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 emerald¿ syringe, luer slip centric tip had illegible scale markings along with certain barrels being bent.Found before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Results: bd did not receive any photos or samples from the customer in support of this complaint, therefore the investigation was limited.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The process we use to print the scale is called "hot stamping system".A metal stamp is heated at around 100ºc.Between the stamp and the barrel, we interpose a special black printing foil.By pressure, the stamp pushes the printing foil and its component is embedded in the barrel wall.The result is a black scale printed on the barrel of the syringe.The reported issue should happened at the end of this process, due to a defective foil reel.In this case the foil did not work as expected, and the scale of the syringe was not printed correctly.The material used to manufacture emerald syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with damaged parts like the tip of the barrel.Based on this fact, we think that the syringe tip bent caused by some inappropriate handling condition or transport of the product before use.

• Brand Name: BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7061322
• MDR Text Key: 93479492
• Report Number: 3002682307-2017-00111
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 307727
• Device Lot Number: 1710184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other