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

Model Number	M00535700
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was delivered to the customer.According to the complainant, during delivery of the product a hairline was found inside the pouch.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 delivered to the customer.According to the complainant, during delivery of the product a hairline was found inside the pouch.There was no procedure involved and the device was not used in the patient.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 2944 captures the reportable event of foreign material present in the device.Block h10: the returned tandem xl was analyzed, and a visual evaluation noted that a hair was found inside the sealed pouch.No other issues with the device were noted.The reported event was confirmed.During visual assessment it was found a hair inside of the sealed pouch.Therefore, it was concluded based on the information available and the analysis performed to the returned device that the investigation conclusion code for this complaint will be documented as manufacturing deficiency due to problems traced to the manufacturing process.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.An investigation to address this issue has been completed.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 10141310
• Report Number: 3005099803-2020-02181
• Device Sequence Number: 2561131
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K833417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 02/09/2022
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 0025186292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1