MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD 3 ML SAFETY SYRINGE

Catalog Number 307864

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 3 ml safety syringe experienced a loose needle.The following information was provided by the initial reporter: syringe with safety device, the needle is loosening, some are loosening as soon as it is inserted into the vial to pull the medicine, they have had no problem so far, but there is the possibility of being inserted into a patient and the needle remaining, thus causing some major problem, as there will be a foreign body in the patient.

Event Description

It was reported that the bd 3 ml safety syringe experienced a loose needle.The following information was provided by the initial reporter: syringe with safety device, the needle is loosening, some are loosening as soon as it is inserted into the vial to pull the medicine, they have had no problem so far, but there is the possibility of being inserted into a patient and the needle remaining, thus causing some major problem, as there will be a foreign body in the patient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-14 h6: investigation summary sample and photo were received for investigation, upon visual inspection, it is possible to observe the incident "needle pulled out of hub".Batch history analysis was performed, quality notifications and maintenance records were verified.It was evidenced the record of a maintenance order for the assembled needle batch 1029898 that could potentially be related to the incident.Possible root cause is associated with a hole wider in the hub, which could impact the cannula fixation in the hub.After the problem in the line was evidenced, the exchange of the hubs was carried out.H3 other text : see h10.

• Brand Name: BD 3 ML SAFETY 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12790198
• MDR Text Key: 284868288
• Report Number: 3003916417-2021-00340
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: Other
• Device Catalogue Number: 307864
• Device Lot Number: 1043939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2021
• 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