MAUDE Adverse Event Report: HAEMONETICS CORP. WOUND DRAIN SET,4.8MM; APPARATUS, AUTOTRANSFUSION

Model Number 01500-16J

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

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

Event Date 12/12/2014

Event Type  Injury  

Event Description

Haemonetics received a report on (b)(6) 2014 for an orthopat wound drain set that was being removed post-op when the tubing broke off, leaving a portion of the tubing inside the pt's wound site.The pt underwent a second surgery to remove the tubing.No info was available for the status of the pt condition or length of hospitalization.

Manufacturer Narrative

Haemonetics received the disposable wound drain kit back for eval.Testing was completed on sample tubing to simulate the root cause of the issue.The testing resulted in the returned sample matching the tubing that was torn from strain on the retained sample tubing.This would indicate that the tubing underwent stress when pulled out of the wound site.The testing is not complete as the tubing has been sent to the supplier for final eval.A supplemental report will be filed upon eval results completion.Haemonetics (b)(4).

Event Description

The supplier provided haemonetics with investigation results of the drain tubing issue.The design history report was reviewed with no non-conformances noted.The actual tubing was unable to be tested due to it being cut prior to being submitted to the supplier.Samples were tested from available inventory for the raw material related to the complaint.The testing showed no characteristics of the event that were described in the complaint.The failure was unable to be recreated unless excessive force was used during tensile testing.The most probable root cause was excessive force during the procedure which broke the drain tube, but without being able to test the actual sample the root cause remains inconclusive.A two year review of post market data from the supplier for this product showed no similar complaints for the drain tubing breaking.

• Brand Name: WOUND DRAIN SET,4.8MM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4417662
• MDR Text Key: 18032770
• Report Number: 1219343-2015-00001
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

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 Expiration Date: 03/31/2017
• Device Model Number: 01500-16J
• Device Catalogue Number: 01500-16J
• Device Lot Number: D14004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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): Required Intervention