MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER PERCUTANEOUS ACCESS NEEDLE; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number M0067001210

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a percutaneous access needle was received with a creased packaging on (b)(6) 2017.According to the complainant, when the device was being stored, it was noted that the product label on the packaging was creased.It was reported that the sterile seal was suspected to be compromised.There was no patient involvement and the defect was noticed prior to a procedure.

Manufacturer Narrative

Investigation results: visual examination of the returned percutaneous access needle pouch revealed that the pouch was received completely closed, the heat seal runs throughout the entire width of the pouch without any breaks.The label is adhered to the packaging and it is legible.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a percutaneous access needle was received with a creased packaging on (b)(6) 2017.According to the complainant, when the device was being stored, it was noted that the product label on the packaging was creased.It was reported that the sterile seal was suspected to be compromised.There was no patient involvement and the defect was noticed prior to a procedure.

• Brand Name: PERCUTANEOUS ACCESS NEEDLE
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6272729
• MDR Text Key: 65596056
• Report Number: 3005099803-2017-00103
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K820867
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: M0067001210
• Device Catalogue Number: 700-121
• Device Lot Number: 19845004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1