MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 3ML LUER LOCK SYRINGE; HYPODERMIC SYRINGE

Catalog Number 990483

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown. device manufacture date: unknown.Results: investigation summary: it was not possible to perform the dhr, maintenance record analysis and quality notification analysis because the batch number was not informed.Without samples or photos, it was not possible perform an investigation and determine the root cause.From this information, it is not possible to confirm the complaint.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 business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: not confirmed: bd was not able to confirm/ reproduce the incident in question.Samples/ photos analysis: it was not received photos from customer to analyze.Qn/ maintenance review: it was not possible to verify the quality notification and maintenance review because the batch number was not informed.Without samples / photos and batch number information, it was not possible to perform an investigation and determine the root cause.

Event Description

It was reported there was difficult plunger movement found while using a bd plastipak¿ 3ml luer lock syringe.It was also reported that the client could not ¿aspire the content, could not pull the plunger, it did not move.¿ there was no report of exposure, injury or medical intervention.

• Brand Name: BD PLASTIPAK¿ 3ML LUER LOCK SYRINGE
• Type of Device: HYPODERMIC 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: 7261606
• MDR Text Key: 100005159
• Report Number: 3003916417-2018-00008
• 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,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990483
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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