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

Model Number KILT

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Lutheran medical center returned this kilt front and back style protective apron with velcro closure (model kilt, manufactured 3/13/2017, serial number (b)(4)) to burlington medical on 5/14/2019 because there were two 1 x 2 inch holes in the protection material.These aprons have a 2-yr manufacturer's warranty.The apron was repaired and returned to the customer.This apron was determined to have the same condition as previously returned aprons, and was manufactured with ve25 from lot # 4703.It was noted that this lot of lead didn't feel the same as previous component material; however, the material met all inspection requirements, so it was used in the manufacture of devices designed to protect against radiation exposure.The other returned devices are referenced in the following mdrs: 1222742-2019-00001, 1222742-2019-00002, 1222742-2019-00003, 1222742-2019-00005, 1222742-2019-00006, 1222742-2019-00007, and 1222742-2019-00008.These aprons are inspected at least annually by the user-facility, and much more often by the technicians who use them.Despite this, burlington medical has decided 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.A 5-day mdr has been filed to capture this remedial action (mdr 1222742-2019-00009).

• 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: 8693070
• MDR Text Key: 207716005
• Report Number: 1222742-2019-00004
• 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
• Report Date: 05/14/2019

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
• Device Model Number: KILT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2017
• 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