MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED 5ML SYRINGE WITH NEEDLE

Catalog Number 302631

Device Problems Break (1069); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter fax #: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0289635.Medical device expiration date: 2025-10-31.Device manufacture date: 2020-10-15.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Examination of the product involved may provide clarification as to the cause for the reported failure.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: the dhr was performed, maintenance record analysis and quality notification analysis and no deviation was found for this batch.No samples / photos were sent by the customer not being possible performing an investigation and determine the root cause for the incident.The manufacturing process are validated with defined acceptance criteria.From these information¿s it is not possible confirm the complaint.The incident identified by this complaint will be monitored to tendency analysis.

Event Description

It was reported that bd solomed¿ 5ml syringe with needle experienced 7 cases of difficult plunger movement, and 7 cases of the tip of the syringe breaking off.The following information was provided by the initial reporter: he informs that he bought the 5ml syringe from bd and that the plunger is hard to apply, he used two syringes and both broke in his arm but it didn't hurt and his pharmacy colleague also used a 5ml syringe and it broke during the application of the medicine but it did not hurt.He informs that these 3 syringes were discarded and he does not have the sample, but he acquired other 3 ml syringes on the same day, but he is unable to inform if he has a problem because he did not use it.He also informs that another 4 times he had the same problem with the 5ml syringes, but he did not complain.

• Brand Name: BD SOLOMED 5ML SYRINGE WITH NEEDLE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12600570
• MDR Text Key: 279955377
• Report Number: 3003916417-2021-00319
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 302631
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/08/2021
• 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