MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; IRRIGATION BULB SYRINGE IN C-SECTION PACK-LF

Catalog Number DYNJ0259839AC

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a cesarean section procedure, a "lip" of the irrigation bulb syringe broke off of the device and fell into the surgical site.Reportedly, the "lip" was found and retrieved by the physician.Despite multiple good-faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the manufacturer.The use of the irrigation bulb syringe at the time of the incident is unknown.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention to retrieved the broken irrigation bulb syringe "lip" 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 a "lip" of the irrigation bulb syringe broke off and fell into the surgical site.

• Type of Device: IRRIGATION BULB SYRINGE IN C-SECTION PACK-LF
• 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: 8777180
• MDR Text Key: 150689040
• Report Number: 1423395-2019-00024
• Device Sequence Number: 1
• Product Code: OHM
• 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: 07/10/2019

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: Health Professional
• Device Catalogue Number: DYNJ0259839AC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization