MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSFLOW¿ SHEATH FLUID; GENERAL PURPOSE

Catalog Number	342003
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, bd bioscience headquarters in san jose, ca has been listed in sections d.3.And g.1.As avantor is an oem manufacturing site.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd facsflow¿ sheath fluid had incorrect information on label.The following information was provided by the initial reporter: distributor have checked actual label they have in the storage for bd facsflow product 342003 and they have informed me that they have product with incorrect gtin - (b)(4).
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131.G.1 - reporting office contact - fahmy razak.G.1 - manufacturing site contact - fahmy razak.H.6 investigation summary: based on the investigation results, the reported issue product with incorrect gtin number was confirmed.Investigation results that were performed on the indicated failure mode were the following: photo provided by bd distributor shows that incorrect gtin number bhr part 342003 lot 2322809810 was reviewed was reviewed.The materials met all the manufacturing specifications prior to release.The possible cause is related to supplier labeling system upgrade and gtin number was changed without going through proper notification.Bd regulatory has reviewed the situation and approved.Corrective action was initiated to address the incorrect gtin number.Bd followed up with the customer and no response was received regarding the resolution.Complaints received for this device and reported condition will continue to be tracked and trended.Regulatory, together with quality, have advised to ¿use as is¿ as there is no impact on the performance or the safety of the patient (risk is negligible) until the inventory is depleted, allowing the product to be distributed.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd facsflow¿ sheath fluid had incorrect information on label.The following information was provided by the initial reporter: distributor have checked actual label they have in the storage for bd facsflow product 342003 and they have informed me that they have product with incorrect gtin - 59077400243326.

• Brand Name: BD FACSFLOW¿ SHEATH FLUID
• Common Device Name: GENERAL PURPOSE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18182835
• Report Number: 2916837-2023-00220
• Device Sequence Number: 15366873
• Product Code: PPM
• UDI-Device Identifier: 00382903420032
• UDI-Public: 00382903420032
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 342003
• Device Lot Number: 23228098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown