MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/8 INCH ROUND PVC WOUND DRAIN WITH NEEDLE; APPARATUS, AUTOTRANSFUSION

Catalog Number 0215018000

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

Device discarded by customer.

Event Description

It was reported that a piece of the drain was left inside the patient about 3 months after the procedure.The user facility supplied additional information reporting that the patient is asymptomatic and that no medical intervention has or will occur until the patient becomes symptomatic.

Manufacturer Narrative

This record is being submitted because the investigation has been completed.Device not returned.

Event Description

It was reported that a piece of the drain was left inside the patient about 3 months after the procedure.The user facility supplied additional information reporting that the patient is asymptomatic and that no medical intervention has or will occur until the patient becomes symptomatic.

Event Description

It was reported that a piece of the drain was left inside the patient about 3 months after the procedure.The user facility supplied additional information reporting that the patient is asymptomatic and that no medical intervention has or will occur until the patient becomes symptomatic.

Manufacturer Narrative

Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.

• Brand Name: 1/8 INCH ROUND PVC WOUND DRAIN WITH NEEDLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• MDR Report Key: 5519935
• MDR Text Key: 41015755
• Report Number: 0001811755-2016-00322
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K952224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0215018000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other