MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE

Catalog Number 307731

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: complaint trending review is not possible to perform since no lot number has been provided.No significance trend is observed for this defect on the reported product family.We have been provided with a picture of the affected sample.The provided picture presented the tip broken.We confirmed the reported issue.Investigation conclusion: we have been provided with a picture of the affected sample.The provided picture presented the tip broken.We confirmed the reported issue.Root cause description: minor damaged in the barrel which produced breakage of the tip during handling of the product in the manufacturing process.

Event Description

It was reported that a bd emerald¿ syringe tip broke off while being removed from the venous lumen permcath device.The syringe was used to withdraw citralock, and then when being removed it broke.Forceps were used to remove the syringe tip.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.

Event Description

It was reported that a bd emerald¿ syringe tip broke off while being removed from the venous lumen permcath device.The syringe was used to withdraw citralock, and then when being removed it broke.Forceps were used to remove the syringe tip.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD EMERALD¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7786917
• MDR Text Key: 117437129
• Report Number: 3002682307-2018-00205
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903077311
• UDI-Public: 382903077311
• 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: 09/06/2018

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 Catalogue Number: 307731
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other