MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. DRAINAGE SET; CAVITY DRAINAGE CATHETER PRODUCTS

Catalog Number AI-01600

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device was placed in the patient's thorax in the icu.After ten days of being in place, the device dislocated due to broken suture wings.As a result, the device was removed but not replaced.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.The patient involved was a (b)(6).

Manufacturer Narrative

(b)(4).Device evaluation: complaint verification testing could not be performed because no sample was returned for analysis.The device history records for the catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of this issue could not be determined based upon the information provided and without a sample.No further action will be taken.

• Brand Name: DRAINAGE SET
• Type of Device: CAVITY DRAINAGE CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5664646
• MDR Text Key: 45474342
• Report Number: 1036844-2016-00271
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K895516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-01600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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 Age: 75 YR
• Patient Weight: 90