MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRINGE,IRRIGATION,BULB,60ML,STERILE

Catalog Number DYND20125

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a bilateral breast augmentation procedure a green ring from the bulb irrigation syringe broke off and then fell into the surgical site.The incident occurred during the middle of the procedure.The surgeon was required to visually remove the green ring from the surgical site with a pair of forceps.The patient was reportedly under general anesthesia at the time of this incident.The procedure did not last longer than expected and the patient did not require additional anesthesia.No impact to the patient or to the patient's stability was reported.No impact to the procedure was reported.A sample was returned for evaluation.The reported product issue was confirmed and the green ring was found to be flash or material resiude from the blub portion of the syringe.No serious injury was reported.No follow-up care was reported.Due to the need for medical intervention to remove the green ring from the surgical site, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during a bilateral breast augmentation procedure a green ring from the bulb irrigation syringe broke off and then fell into the surgical site.

• Type of Device: SYRINGE,IRRIGATION,BULB,60ML,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7499826
• MDR Text Key: 108226039
• Report Number: 1417592-2018-00032
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYND20125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 47