MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD PHASEAL; SECONDARY SET C61

Catalog Number	515302
Medical Device Problem Codes	Defective Component (2292); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal package seal was compromised, leading to tubing damage.The following information was provided by the initial reporter: "the tubing was found in massive damaged upon opened.Sealing of the package affected the tubing and damaged the tubing.".
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Product 515302, lot 1024993, qty (b)(4) 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 (b)(4).After detailed investigation, it can be said that there is one potential root cause which could be connected with packaging process.During sealing process packaging machine sliced the infusion set, because product was not placed properly in nest.Based on picture provided from the customer, this assumption can be confirmed and calcified as human error.Operator on packaging department were re - trained on (b)(4)- control specification, attachment 2 retraining record.This batch have been packed at packaging machine multivac (b)(4).If customer provide additional information that could help to conduct more detail investigation, investigation of this customer complaint will be revised, as needed.H3 other text : see narrative.
Event or Problem Description
No additional information provided.

• Brand Name: BD PHASEAL
• Common Device Name: SECONDARY SET C61
• 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: 17999989
• Report Number: 2243072-2023-01923
• Device Sequence Number: 7277128
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 05/21/2026
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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