MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SINGLE ACTION PUMPING SYSTEM; CATHETER, UROLOGICAL

Model Number	M0067201000
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an unopened single action pump device was checked during stocking or inventory on (b)(6) 2021.During stocking or inventory, a hair was noted inside the package.Reportedly, there was no damage to the packaging and the sterile seals were intact.There was no patient or procedure involved.
Event or Problem Description
It was reported to boston scientific corporation that an unopened single action pump device was checked during stocking or inventory on (b)(6) 2021.During stocking or inventory, a hair was noted inside the package.Reportedly, there was no damage to the packaging and the sterile seals were intact.There was no patient or procedure involved.
Additional Manufacturer Narrative
Block h6: medical device problem code a1802 captures the reportable event of foreign material found in the packaging.Block h10: investigation results the returned irrigation device was analyzed and a visual evaluation noted that the pouch was unopened and the seals were in good condition.A hair was also observed inside the pouch, thereby confirming the reported event.Microscopic inspection was performed which confirmed the hair inside the device pouch.The most probable root cause is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: correction: d4 (model number, lot number, catalog number and unique identifier (udi) #).

• Brand Name: SINGLE ACTION PUMPING SYSTEM
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12777663
• Report Number: 3005099803-2021-05851
• Device Sequence Number: 14982372
• Product Code: KOD
• UDI-Device Identifier: 08714729045069
• UDI-Public: 08714729045069
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K870557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2025
• Device Model Number: M0067201000
• Device Catalogue Number: 720-100S
• Device Lot Number: 0027982120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown