MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE; HYPODERMIC SYRINGE

Catalog Number 300865

Device Problem Burst Container or Vessel (1074)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a bd plastipak¿ 50ml concentric luer lock syringe exploded during filling.Both the nurse and patient were exposed to blood, but there was no report of injury or medical interventions.

Manufacturer Narrative

Initial mdr stated 09/14/2014 as the "date received by manufacturer".However, actual date is 09/14/2017.Investigation: no sample neither picture has been received for investigation.Ten retained samples of 50ll lot 1704235p are evaluated.On visual inspection of these ten retained samples, no damage or molding defect can be observed in any of them that could have caused this defect.Dhr of lot 1704235p is reviewed not finding any annotation or deviation regarding the alleged defect.The areas where pieces run in manufacturing area are protected to avoid damage on the product.The ten retained samples are filled with water (with blue colorant for easy visibility) using a 14ga needle, not observing any breakage in the syringe.On inspection at 10x no damage or molding defect can be observed in the tip of these syringes.Tip and thread verification is done with an iso594 reference gauge (#10-419/1 and #10-413) and the ten syringes meet iso594.During manufacturing process, final products are sampled and subjected to visual inspections according to procedures (jg-301, jg-302, jg-303 and jg-304).Process: visual inspection.Printing 30 samples per hour, after any intervention in the equipment or once at the beginning of the shift.Assembly: 30 samples per hour, after any intervention in the equipment or once at the beginning of the shift.Packing 1 step per hour, after any intervention in the equipment, after a stop of more than 1 hour, once at the beginning of the shift, when film or paper roller are changed, after maintenance.Packaging: 1 shelf-package per pallet.Since no incidence has been found during manufacturing process related to this defect, no defect has been found in the ten retained samples evaluated, and the alleged defect cannot be reproduced, the root cause cannot be determined.

• Brand Name: BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6930896
• MDR Text Key: 89037157
• Report Number: 3003152976-2017-00058
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1704235P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other