MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML CATHETER TIP BRAZIL; IRRIGATING SYRINGE

Catalog Number 303553

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed for provided material number 303553 and lot number 0237611.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a used 50ml syringe out of the packaging blister.The syringe has barrel luer damage.Based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed, but without a physical sample investigation a probable root cause could not be offered.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 3 syringes 50ml catheter tip brazil broke during their liposuction procedures.Additionally, it was reported that the health care workers were exposed to blood.The following information was provided by the initial reporter, translated from (b)(6) to english: she reports that the syringe was used for liposuction and that now the 50ml syringe is not as resistant and they break during the procedure.Client reports that they had more cases, but only on (b)(6) the doctor called the rapporteur to report what happened.There was no harm to the patient, but there was a delay in the procedure and the doctor, instrumentador and nurse were "washed" with blood.Info add: the syringes that showed the deviation are from the same batch informed.Three syringes had the deviation.There was no harm to the professional / patient.There was no exposure to mucous membranes or skin.Professionals were not subjected to examination or treatment due to exposure.

• Brand Name: SYRINGE 50ML CATHETER TIP BRAZIL
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11335375
• MDR Text Key: 232845645
• Report Number: 1911916-2021-00122
• Device Sequence Number: 1
• Product Code: KYZ
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303553
• Device Lot Number: 0237611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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