MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

Catalog Number 300865

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/15/2019

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 there was a crack in barrel during administration with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: syringe prepared and administered intravenously with pump at speed 3.During the administration (20ml remaining in the syringe) the patient fell at 30 systolic arterial tension (strong hypotension).Alerted, the hcw sees a product leakage with the current syringe.She changes it and finds a crack at the 15ml graduation.

Event Description

It was reported that there was a crack in barrel during administration with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter, translated from french to english: syringe prepared and administered intravenously with pump at speed 3.During the administration ( 20ml remaining in the syringe) the patient fell at 30 systolic arterial tension (strong hypotension).Alerted, the hcw sees a product leakage with the current syringe.She changes it and finds a crack at the 15ml graduation.

Manufacturer Narrative

Investigation: one sample was returned for investigation.Upon visually inspecting the product, damage was observed between the 15ml and 20ml marking as well as near the barrel flags, which lead to the leak reported.A device history review was performed for reported lot 1902233, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.The damage noted is consistent with the assembly wheels that guide the barrel in the machine.While we could not identify a direct issue, it was determined this instance likely occurred as a result of the product jamming within the manufacturing equipment.

• Brand Name: BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8591783
• MDR Text Key: 145950672
• Report Number: 3003152976-2019-00313
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 300865
• Device Lot Number: 1902233
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other