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

Catalog Number 300865

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Chemical Exposure (2570)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Investigation: no samples or pictures are returned for investigation.Ten retained samples of 50ll lot 1705234p 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 leakage.The stopper is correctly assembled to the plunger in all of them.Dhr of lot 1705234p 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.During different manufacturing processes, final products are sampled and subjected to visual inspections according to procedures (jg-301, jg-302, jg-303 and jg-304).Process.Visual inspection molding 2 injections per shift 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 leak test is performed with the 10 retained samples according to procedure pc-039 and iso (b)(4) 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.In addition retaining ring test is done with the ten retained samples to check the force required to separate the plunger-stopper from the barrel.Results meet specification jg-600 (min.2.5lbs).This issue is not related to a manufacturing defect.Since no incidence happened during manufacturing process and retained samples meet (b)(4), a definitive root cause cannot be determined.Corrective action capa (b)(4) is open to investigate the root cause and reduce the occurrence of this defect.(b)(4).

Event Description

It was reported that a bd plastipak¿ 50ml concentric luer lock syringe had a loose plunger causing liquid to leak.The nurse was exposed to the liquid but there was no report of injury or medical interventions.

Manufacturer Narrative

Bd awareness date was reported incorrectly.The correct awareness date was 09/14/2017.

• Brand Name: BD PLASTIPAK¿ 50ML 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
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6929080
• MDR Text Key: 90312295
• Report Number: 3003152976-2017-00053
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: 04/30/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1705234P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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