MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP

Catalog Number 307727

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: an investigation has been completed without a picture or an available sample to review.As a result, our group cannot verify the reported issue.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 believe that the syringe tip could break as a consequence of any imperceptible damage in the barrel at the moment of the use or some strong condition during handling or use of the product.Based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.Bhr review: 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.Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots #7296636, #7318871, #7311702, #7282421, and #7296266, and no problems, defects or qn related to the reported issue were found.Root cause analysis 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 could break as a consequence of any imperceptible damage in the barrel at the moment of the use or some strong condition during handling or use of the product.Confirmation: no sample or picture available.We could not confirm the reported issue.Capa determination: no - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.

Event Description

It was reported that the tip of a bd emerald¿ 2ml syringe, luer slip centric tip broke off while trying to flush a catheter and got stuck inside the catheter until safely removed.There was no report of exposure, injury or medical intervention.

• Brand Name: BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP
• Type of Device: 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: 7296836
• MDR Text Key: 101158611
• Report Number: 3002682307-2018-00028
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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: 307727
• Device Lot Number: 1711178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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