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

Catalog Number 300865

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced difficult plunger movement and was involved with a serious injury -hypotension.The following information was provided by the initial reporter: sku 187508 syringe 50ml luer lock bd n300865 1 x 60.Syringe infusion pumps ¿ drug delivery failure.It became most notable during phase 1 of the pandemic.We had changed over from old pumps to new pumps, and we initially thought it was a programming issue.To alleviate it we increased the pump occlusion pressure but this did not help.We took syringe samples to our physics lab which showed a high pressure across the system.It convincingly became a syringe issue when we started to get the same issue in theatre using the old pumps.Any harm on a patient? -thankfully no long-term harm but several patients had significant hypotensive episodes when noradrenaline failed.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced difficult plunger movement and was involved with a serious injury -hypotension.The following information was provided by the initial reporter: sku 187508, syringe 50ml luer lock bd n300865 1 x 60.Syringe infusion pumps ¿ drug delivery failure.It became most notable during phase 1 of the pandemic.We had changed over from old pumps to new pumps, and we initially thought it was a programming issue.To alleviate it we increased the pump occlusion pressure but this did not help.We took syringe samples to our physics lab which showed a high pressure across the system.It convincingly became a syringe issue when we started to get the same issue in theatre using the old pumps.Any harm on a patient? -thankfully no long-term harm but several patients had significant hypotensive episodes when noradrenaline failed.

• 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: 11405532
• MDR Text Key: 244760103
• Report Number: 3003152976-2021-00117
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other