MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML14GA 1-1/4IN PERFUSION

Catalog Number 300136

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 11/26/2018

Event Type  Death  

Manufacturer Narrative

Date of death: unknown.The actual date of death is unknown.(b)(6) 2018 has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: based on the available information we are not able to identify a root cause at this time.Rationale: bd was not able to duplicate or confirm the customer¿s indicated failure as no information or sample was provided.

Event Description

It was reported that syringe 50ml perfusion was disconnected during use.This caused a considerable loss of blood, which led to death.The following information was provided by the initial reporter: disconnection of the luer-lock connection bd insulin syringe 50ml, considerable blood loss which led to death.Samples were secured by the police.Semi-stationary treatment case multimorbid, tracheotomized patient.Infection status: (b)(6).The (b)(6) trade inspectorate asked us to report this incident.Unfortunately, we cannot give any more precise information about the affected samples, as these were ensured by the police.There is an expert opinion, which we unfortunately do not have.The (b)(6) criminal police is conducting the case under the (b)(4).: by (b)(4).

Manufacturer Narrative

The following fields have been updated with corrections: b.5.Describe event or problem: the event description has been updated with a new medical device brand name.D.1.Medical device brand name: syringe 50ml14ga 1-1/4in perfusion.D.2.Medical device type: fpa.D.2.Medical device catalog #: 300136.D.4.Unique identifier (udi) #: (b)(4).

Event Description

It was reported that syringe 50ml14ga 1-1/4in perfusion was disconnected during use.This caused a considerable loss of blood, which led to death.The following information was provided by the initial reporter: disconnection of the luer-lock connection bd insulin syringe 50ml, considerable blood loss which led to death.Samples were secured by the police.Semi-stationary treatment case multimorbid, tracheotomized patient.Infection status: mrsa / orsa.The munich trade inspectorate asked us to report this incident.Unfortunately, we cannot give any more precise information about the affected samples, as these were ensured by the police.There is an expert opinion, which we unfortunately do not have.The ingolstadt criminal police is conducting the case under the az.: by (b)(4).

• Brand Name: SYRINGE 50ML14GA 1-1/4IN PERFUSION
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9723256
• MDR Text Key: 179992471
• Report Number: 3003152976-2020-00068
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death