MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 7.0MM 3/4 PERFORATION FLAT SILICONE WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0212010000

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2014

Event Type  Injury  

Event Description

It was reported that the tubing broke inside the patient upon removal after a spine procedure.The day after the procedure, the incision was opened up and the rest of the broken drain was removed.There was no additional treatment required.There were no adverse consequences to the patient related to the event.

Manufacturer Narrative

The device will not be returned to the manufacturer for evaluation so the root cause cannot be determined.Device not returned for investigation.

• Brand Name: 7.0MM 3/4 PERFORATION FLAT SILICONE WOUND DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3816195
• MDR Text Key: 4393910
• Report Number: 0001811755-2014-01791
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970714
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0212010000
• Device Lot Number: 14049012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• 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
• Patient Outcome(s): Other