MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ W/SND HYPO-POSIFLUSH¿ SYRINGE

Catalog Number 307875

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

(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¿ w/snd hypo-posiflush¿ syringe burst during procedure.There was no damage or medical intervention.The professionals were properly dressed, there was no blood contact with skin or mucous membranes.The incident occurred in the hemodynamics sector during blood collection.Collection is usually done on the jugular or femoral.He reports that the syringe is attached to the catheter of hemodynamics (deep catheter) and that the pressure applied is little higher than in other blood collect, because these veins are larger, mainly with the use of contrast, but not enough to explode the syringe.Informs other similar cases occurred before.No sample.

Manufacturer Narrative

Investigation summary: samples/ photos analysis: no image or sample was received.Dhr review: the batch record was verified and the manufacturing date for this batch was november 11th to 13th, 2015.The process inspections were performed at proper frequency and no records of this defect were found.Qn review: no quality notification (qn) that could related to defect were observed.Maintenance review: no maintenance record that could related to defect were observed.Investigation conclusion: not confirmed: bd was not able to confirm/ reproduce the incident in question.Due the lack of sample or picture availability, it was not possible perform the defect evaluation, thus it not possible confirm the root cause to the occurrence.

• Brand Name: BD¿ W/SND HYPO-POSIFLUSH¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7492713
• MDR Text Key: 107730493
• Report Number: 3003916417-2018-00073
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 307875
• Device Lot Number: 5289212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other