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

Catalog Number 300865

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger on a bd plastipak¿ concentric luer lock syringe is difficult to move and takes ¿more force¿ to draw and deliver medications.There was no report of medical interventions.

Manufacturer Narrative

Investigation summary: it has been received 2 unused samples of 50ll lot 1711263 ref.300865 and 1 sealed sample of 50ll lot 7266840 ref.309653.This second reference is not evaluated since it is not manufactured at bd (b)(4) plant.Dhr of lot 1711263 has been reviewed not finding any annotation or deviation regarding the alleged defect.On checking the results of silicone weight, break out and sustaining force tests performed during manufacturing process of lot 1711263, they are within specification limits.Silicone weight, break out and sustaining force tests are done with the two samples received according to procedures.Results meet specification limits.No defect can be found in the blisters of both samples.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.According to results obtained from tests performed with samples received and the results during manufacturing process, no manufacturing defect has been found in the samples received related to difficult to move the plunger or related to packaging.Defect: plunger difficult to move.It has been received 2 unused samples of 50ll lot 1711263 ref.300865 and 1 sealed sample of 50ll lot 7266840 ref.309653.This second reference is not evaluated since it is not manufactured at bd (b)(4) plant.Dhr of lot 1711263 has been reviewed not finding any annotation or deviation regarding the alleged defect.On checking the results of silicone weight, break out and sustaining force tests performed during manufacturing process of lot 1711263, they are within specification limits (jg-500 for 50ml syringes break out force max.9 lbs, sustaining force max.5lbs; silicone weight ref: 6mg, max: 25mg ).Silicone weight, break out and sustaining force tests are done with the two samples received according to procedures (b)(4).Results meet specification limits.No defect can be found in the blisters of both samples.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 (jg-301, jg-302, jg-303 and jg-304): visual inspection.Molding: 2 injections per shift.Printing: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 32 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, and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot.Primary packaging: once in the first pallet and once in last pallet of the lot.According to results obtained from tests performed with samples received and the results during manufacturing process, no manufacturing defect has been found in the samples received related to difficult to move the plunger or related to packaging.Investigation conclusion: according to results obtained from tests performed with samples received and the results during manufacturing process, no manufacturing defect has been found in the samples received related to difficult to move the plunger or related to packaging.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7325923
• MDR Text Key: 102081638
• Report Number: 3003152976-2018-00069
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1711263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other