MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS UNSPECIFIED BD INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd unspecified bd infusion set was damaged.The following information was received by the initial reporter with the verbatim: while administering methotrexate, nurse noticed leaking at the connection site.Stopped infusion, looked at connection, and noted a hole in the side of the max zero cap.Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.

Manufacturer Narrative

An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: lot 8a03389 was manufactured on 01/26/2018 in the line convex 2 pc (ost), with a total of (b)(4) ea.Compliance engineer performed a batch record review on 11/23/2020, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material 1156501 and manufacturing order 1395549.The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: one photograph associated with this case was received and no unused return sample was expected.Conclusion summary of the related event: material, method/process, manpower and measurement sections were reviewed, and it is considered none of them interfered on the incidence of the root cause, also, these sections and possible opportunities were previously covered.Based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented, the root cause for this failure mode was identified as machine.As observed during this investigation the contributor factors to this failure mode were the following: a) condition of the yamaha arm, b) condition of vision system cameras, c) variance in the materials, cause variation in the placement.This is causing the overall variation 0.6.This accumulation of variation causes the complaint in section 1.To maintain acceptable levels of variation the maintenance for the arm will be improved.And base on the rate of complaints and the variation identify, codes with a rate higher than 10 complaints per million will be block and manufactured on the improve convex 2 pc in building 8a.Actions were taken on corrective action / preventive actions (capa) plan.The investigation associated with related event has been approved and is complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

• Brand Name: UNSPECIFIED BD INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION 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: 17917557
• MDR Text Key: 325705860
• Report Number: 2243072-2023-01831
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male