MAUDE Adverse Event Report: BURLINGTON MEDICAL BURLINGTON MEDICAL; LEAD APRON

Device Problems Nonstandard Device (1420); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Event Description

Between november 2016 and march 2017, burlington medical received some lots of lead manufactured by the kennedy company (lead free,.25mm pb.Eq., lot numbers ken 4686, ken 4687, ken 4690, ken 4693, ken 4697, ken 4719, ken 4723) that didn't have the same tactile properties as lots previously received.However, when weighed, these lots conformed to specifications.Therefore, this lead was used as a component in the manufacturer of devices that protect against radiation exposure.On may 21, 2019, management was notified that 8 aprons from these lots (mdr 1222742-2019-00001, 1222742-2019-00002, 1222742-2019-00003, 1222742-2019-00004, 1222742-2019-00005, 1222742-2019-00006, 1222742-2019-00007, and 1222742-2019-00008) had been returned for repair or replacement.While these aprons were no longer covered by the 2-year warranty, upon investigation, quality control noted that this was a trend that needed to be addressed with remedial action.Mdrs were filed later than 30 days from the from the date the company received the returns, but within 30 days of the company becoming aware of the trend (march 21, 2019).None of these aprons individually would require an mdr, as initial analysis indicated advanced wear and tear (possibly caused by the end-user), rather than an issue that might impact public health.These protective aprons are inspected at least annually by the user-facility, and much more often by the technicians who use them.Despite this, burlington medical decided on june 3, 2019 to take a very conservative stance and recall all protective devices made with material that was noted to have slightly different properties (didn't feel the same as previous material).The total number of products to be recalled is 4,201 and the majority are thyroid shields.This 5-day mdr is being filed to capture this remedial action.

Manufacturer Narrative

The initial submission that describes the recall was erroneously filed as a 5-day report.This 30-day report is being submitted for the remedial action, as described in the first submission.

• Brand Name: BURLINGTON MEDICAL
• Type of Device: LEAD APRON
• Manufacturer (Section D): BURLINGTON MEDICAL; 7 elmhurst st.; newport news VA 23603
• Manufacturer (Section G): BURLINGTON MEDICAL; 7 elmhurst st; newport news VA 23603
• Manufacturer Contact: john daspit ; 7 elmhurst dr; newport news, VA 23603 ; 7579685846
• MDR Report Key: 8693927
• MDR Text Key: 148180456
• Report Number: 1222742-2019-00009
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1