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

Catalog Number DYND20125

Device Problems Material Fragmentation (1261); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified surgical procedure, a "small bit of plastic" dropped off of the sterile bulb irrigation syringe into the surgical incision.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.It is unknown what medical intervention was required to retrieve the "small bit of plastic" from the surgical incision site.There was no serious injury reported related to this event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during an unidentified surgical procedure, a "small bit of plastic" dropped off of the sterile bulb irrigation syringe into the surgical incision.

• Type of Device: SYRINGE,IRRIGATION,BULB,60ML,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 8060176
• MDR Text Key: 128325307
• Report Number: 1417592-2018-00122
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND20125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/12/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other