MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD PHASEAL; SECONDARY SET

Catalog Number	515302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal was leaking.The following information was provided by the initial reporter: "i would like to file a product feedback - chemo drip leaking from the top of secondary set batch: 1024993 exp: 05/2026.Photos attached - wet inside zipper bag.Product returned by daycare oncology nurse - visible droplets inside zipper bag with the product.Day nurse claimed it was leaky from the top of secondary set.Pharmacy redo a new product for nurse and discarded the hazardous leaky product.".
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Product 515302, lot 1024993, qty 20160 was produced in oct 2022.According to dhr, there were no quality notifications observed during manufacturing process.Manufacturing process was conducted in accordance with document (b)(4) and all quality control activities have been performed according to quality specification 10-0160 and 10-0255.Risk assessment has been performed based on document (b)(4) peura phaseal c61 and it can be confirmed that this failure mode (leakage) has been included into mentioned document, and appropriate risk control have been set up.Based on the photo forwarded by the customer, it is difficult to see the reported defect.It is not visible whether there is damage to the solid component or whether it is a damaged tube.During assembly, the product undergoes a 100% leak inspection, and this is defined in procedure 15-0137.If the leaking product is detected in the 100% testing process, it will be separated as scrap.Also, 100% inspection is performed according to 10-0160 for critical defect characterized as c4.2 deficiency in the hermeticity of the product, per iso8536-4:2010.Visual inspection of the retain sample did not reveal any defect.The functional test also found no leakage on the set., please see attachment 1.With a 100% inspection, we prevent a defective product from reaching the customer.It is possible that the mentioned defect was caused by the customer's handling or by some other method unknown to us.
Event or Problem Description
No additional information provided.

• Brand Name: BD PHASEAL
• Common Device Name: SECONDARY SET
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18373017
• Report Number: 2243072-2023-02226
• Device Sequence Number: 20763918
• Product Code: ONB
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 515302
• Device Lot Number: 1024993
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/28/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown