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

Catalog Number 300613

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 the welded seam of the bd plastipak¿ syringe's primary packaging was loose.

Manufacturer Narrative

Investigation summary: it has been received 5 unused samples received of 20ls lot 1811299 for investigation.Upon visual inspection of these 5 samples, it can be observed the 5 blisters are open-seal at one side because they have been wrongly cut.Dhr of lot 1811299 has been reviewed not finding any annotation or deviation regarding the alleged defect.During primary packing process film and paper are guided along a chain in the packing machine.Once the blisters are sealed, longitudinal and transversal cutters cut the blisters.A photo-cell also detects when paper is moved from the correct position and alarm message alerts to operator about it in packaging process.A failure in this photo-cell has caused the alleged defect.According to inspection plan procedure jg-500, (b)(4) units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): 1.Visual inspection molding: 2 injections per shift.Printing: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 24 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.2.Functional inspection printing: once in the first pallet, once in the pallet at the middle of the lot and once in last pallet of the lot.Assembly: once in the first pallet, once in the pallet at the middle of the lot and once in last pallet of the lot.Primary packaging: once in the first pallet, once in the pallet at the middle of the lot and once in last pallet of the lot.Although no issues were identified and manufacturing record stablished that all production and quality processes were carried out normally, we can confirm that the root cause of the non-conformance is related with a movement of the paper in packaging machine from its correct position, causing open blisters when cutters cut.Based on all the preventive measures and our stringent in ¿process inspection plan, we are certain that this should be an isolated issue and any recurrence is really unlikely based on no quality notification was opened during manufacturing process of this lot.Root cause: failure paper position in packaging machine and failure in photo-cell detection.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the welded seam of the bd plastipak¿ syringe's primary packaging was loose.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8302320
• MDR Text Key: 136861924
• Report Number: 3003152976-2019-00124
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 300613
• Device Lot Number: 1811299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other