MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

Catalog Number 990687

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone: (b)(6).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 bd plastipak¿ luer-lok¿ syringe stopper was loose from the plunger.Found during use when aspiration of saline solution, before use in patient.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: samples/ photos analysis: a sample was received with stopper separation from plunger.Dhr review: lot 7304564 was manufactured in nov / 2017.(the batch analyzed is the molded component batch).The inspections carried out during the production process were verified and no records of this defect were found or anything that could clearly indicate the cause of the defect claimed in the history of the lot.The current controls for detecting the defect are performed through visual inspection with 2 hours frequency.Qn/ maintenance review: there are no quality notification (qn).In the history of maintenance records was found occurrence under order number (b)(4) leakage of material in the injection nozzle.Leakage of material in the nozzle suggests a decrease in the injected amount of material and may cause under filling the cavities investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question.Dhr analysis was performed and no deviation was found.During the verification of the maintenance records it was possible to find cause of the defect whose available sample was analyzed and it was possible to confirm the defect in the stopper assembly region.The probable cause for the defect is related to leakage of material in the nozzle that caused a decrease of the injected material and may have caused under filling of the cavities.The problem correction was performed according to order (b)(4).

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7334135
• MDR Text Key: 102339269
• Report Number: 3003916417-2018-00029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 990687
• Device Lot Number: 7300716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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