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 Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the tip of a bd emerald¿ 2ml syringe, luer slip centric tip broke off during use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: sample evaluation: n/a.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.Syringes were packed in machine (b)(4) (july 6 - 8th, 2017).Syringes were assembled in machine (b)(4), in lot #7187063, #7083155, #7076204, and 7160167.Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lots #7187033, #7160140, #77083124, #7055064, #7062452, #7076180, #7072489, and #7062452, and no problems, defects or qn related to the reported issue were found.Investigation conclusion: 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 broke caused by some inappropriate handling condition or transport of the product before use.Confirmation: no picture or sample returned for evaluation.No issues found in the bhr review.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.

• 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
• MDR Report Key: 7296532
• MDR Text Key: 101164946
• Report Number: 3002682307-2018-00031
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

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: 06/30/2022
• Device Catalogue Number: 307727
• Device Lot Number: 1707155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other