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

Catalog Number 300865

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 with the use of the bd plastipak¿ 50ml concentric luer lock syringe there was an issue with the stopper.It was stated ¿when using braun pumps the customer has observed that the pressure of the stopper in the syringes is not assured/even, so the little patients don't get accurate infusion therapy.The customer assumes, the reason for it is the flexibility of the rubber stopper in combination with the expansion of the barrel".There was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: no physical samples or picture samples displaying the condition reported were available for examination.W were unable to fully investigate this incident.Ten retained samples of 50ll of lot 1711247 are evaluated.Upon visual inspection of these 10 retained samples, no damage or molding defect can be observed in them that could be related to the alleged defect.Dhr of lot 1711247 is reviewed not finding any annotation or deviation regarding the alleged defect.Investigation conclusion: since no issues were identified during manufacturing process and manufacturing record established that all production and quality processes were carried out normally and samples evaluated meet specification limits, we can confirm that the root cause of the non-conformance is not related to a manufacturing defect.

• 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: 7475835
• MDR Text Key: 107594039
• Report Number: 3003152976-2018-00177
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1711247
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other