MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE

Catalog Number 300629

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

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¿ syringe there was an issue with leakage.It was stated ¿the client took a 20ml ll syringe to prepare medication.During aspirating medication into syringe, client found syringe plunger had captured the liquid (medication) in between the plunger.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

H.6.Investigation summary: one used sample without blister has been received for investigation.Upon visual inspection of this sample it can be observed leakage past the stopper in a 20ll syringe.The stopper is correctly assembled to the plunger.It is disassembled not observing any damage or molding defect in plunger rod that could have caused this defect.Dhr of lot 1504219 has been reviewed not finding any annotation or deviation regarding the alleged defect.In the assembly station tightness test is done to every syringe.In case any fails, it is rejected automatically to scrap.Ten retained samples of 20ll lot 1504219 are evaluated.Upon visual inspection of the ten retained samples, no damage or molding defect can be observed in any of them and the stopper is correctly assembled to the plunger in all of them.Leak test is performed with the 10 retained samples according to procedure pc-039 and iso 7886-1 annex d and no leakage happens in any of them.The syringes are disassembled not observing any damage or molding defect in the barrel or in the plunger rod that could have caused the alleged defect.Leak test is not performed with the used sample received since it is used and result could not be reliable (this syringe is single use).Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Visual inspection molding: 2 injections per shift.Printing: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.Functional inspection printing: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.Assembly: once in the first pallet, once in the middle of the lot and once in last pallet of the lot -primary packaging: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.Investigation conclusion: this issue is not related to a manufacturing defect.Since no incidence happened during manufacturing process and retained samples meet iso7886 annex d, a definitive root cause cannot be determined.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7459203
• MDR Text Key: 106636076
• Report Number: 3003152976-2018-00173
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 300629
• Device Lot Number: 1504219
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other