MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TANDEM XL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00535700
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 a tandem xl was picked up by the distributor staff.When the device was picked up by the distributor staff for delivery, a hair was found inside the pouch of the device.Reportedly, there was no damage noted on the packaging of the device and the packaging was unopened and completely sealed.There was no procedure involved and the device was not used in the patient.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was picked up by the distributor staff.When the device was picked up by the distributor staff for delivery, a hair was found inside the pouch of the device.Reportedly, there was no damage noted on the packaging of the device and the packaging was unopened and completely sealed.There was no procedure involved and the device was not used in the patient.
Additional Manufacturer Narrative
Block e1 (initial reporter address 1): (b)(6).Block e1 (initial reporter phone): (b)(6).Block h6 (device codes): medical device problem code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h10: the returned tandem xl in its sealed package was analyzed, and a visual evaluation noted that a hair was inside the sealed package.The heat seal runs throughout entire length of the pouch without any breakage.A media inspection of the photos provided by the customer show a hair inside the pouch.No other problems with the device were noted.The reported event of foreign matter inside the package was confirmed.Upon analysis, it was found that a hair was inside the sealed package, which was also verified with the pictures provided by the customer.Based on all gathered information, the conclusion code for this complaint will be documented as manufacturing deficiency with a probable cause owner of bsc manufacturing due to problems traced to manufacturing process.The investigation to address this problem has been completed.The investigation found that the foreign matter was missed by the packaging builder when the packaging unit was confirmed to be free of foreign matter.Communication to the packaging builder was performed regarding this event.A review of the manufacturing documentation for this device did not identify any anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: TANDEM XL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11504583
• Report Number: 3005099803-2021-00829
• Device Sequence Number: 14147483
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K833417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: Other
• Device Expiration Date: 01/08/2023
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 0026602703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1